Frequencies for enfrep20170809 dataset : by Jean Roth , jroth@nber.org , 10 Aug 2017 Frequencies for producttype variable in enfrep20170809 dataset : Product | Type | Freq. Percent Cum. ------------+----------------------------------- Biologics | 3 3.49 3.49 Devices | 33 38.37 41.86 Drugs | 22 25.58 67.44 Food | 25 29.07 96.51 Veterinary | 3 3.49 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for eventid variable in enfrep20170809 dataset : Event ID | Freq. Percent Cum. ------------+----------------------------------- 76385 | 2 2.33 2.33 76514 | 1 1.16 3.49 76701 | 1 1.16 4.65 77207 | 1 1.16 5.81 77405 | 1 1.16 6.98 77474 | 1 1.16 8.14 77484 | 3 3.49 11.63 77490 | 1 1.16 12.79 77508 | 1 1.16 13.95 77533 | 4 4.65 18.60 77576 | 1 1.16 19.77 77601 | 2 2.33 22.09 77638 | 2 2.33 24.42 77640 | 1 1.16 25.58 77648 | 1 1.16 26.74 77652 | 5 5.81 32.56 77653 | 1 1.16 33.72 77663 | 9 10.47 44.19 77669 | 1 1.16 45.35 77671 | 4 4.65 50.00 77674 | 3 3.49 53.49 77677 | 1 1.16 54.65 77700 | 5 5.81 60.47 77732 | 1 1.16 61.63 77734 | 1 1.16 62.79 77755 | 1 1.16 63.95 77756 | 1 1.16 65.12 77757 | 1 1.16 66.28 77759 | 1 1.16 67.44 77762 | 1 1.16 68.60 77771 | 1 1.16 69.77 77779 | 1 1.16 70.93 77781 | 1 1.16 72.09 77805 | 1 1.16 73.26 77806 | 1 1.16 74.42 77810 | 16 18.60 93.02 77813 | 1 1.16 94.19 77821 | 2 2.33 96.51 77832 | 1 1.16 97.67 77835 | 1 1.16 98.84 77847 | 1 1.16 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for status variable in enfrep20170809 dataset : Status | Freq. Percent Cum. ------------+----------------------------------- Completed | 1 1.16 1.16 Ongoing | 80 93.02 94.19 Terminated | 5 5.81 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for recallingfirm variable in enfrep20170809 dataset : Recalling Firm | Freq. Percent Cum. ----------------------------------------+----------------------------------- Apace KY LLC | 2 2.33 2.33 Bayer HealthCare Pharmaceuticals, Inc. | 3 3.49 5.81 Cafe Spice GCT DBA Zaika Flavors of I.. | 1 1.16 6.98 Clif Bar & Company | 5 5.81 12.79 Dr. Reddy's Laboratories, Inc. | 1 1.16 13.95 Evanger's Dog & Cat Food Co | 2 2.33 16.28 Fusion IV Pharmaceuticals, Inc. dba A.. | 1 1.16 17.44 GE Inspection Technologies, LP | 1 1.16 18.60 General Mills, Inc | 1 1.16 19.77 Greatbatch Medical | 2 2.33 22.09 Hospira a Pfizer Company | 4 4.65 26.74 In2Bones, SAS | 1 1.16 27.91 Mississippi Valley Reg Bld Ctr | 2 2.33 30.23 Myelotec, Inc. | 1 1.16 31.40 Nisbet Oyster Co Inc | 1 1.16 32.56 Olympus Scientific Solutions Americas | 1 1.16 33.72 Ortho Solutions Inc | 1 1.16 34.88 PD-Rx Pharmaceuticals, Inc. | 1 1.16 36.05 Precision Dose Inc. | 1 1.16 37.21 Primavera Nueva | 1 1.16 38.37 Professional Complementary Health For.. | 1 1.16 39.53 Quidel Corporation | 1 1.16 40.70 Sami's Pita Bakery, Inc. | 5 5.81 46.51 Sentinel CH SPA | 1 1.16 47.67 Smallbatch Pets, Inc. | 1 1.16 48.84 Soft Computer Consultants, Inc. | 1 1.16 50.00 Sorin Group USA, Inc. | 16 18.60 68.60 Spectranetics Corporation | 1 1.16 69.77 Stryker Neurovascular | 4 4.65 74.42 Teva Pharmaceuticals USA | 2 2.33 76.74 Threshold Enterprises Ltd | 1 1.16 77.91 Time-Cap Laboratories, Inc. | 1 1.16 79.07 United Blood Services | 1 1.16 80.23 United Natural Trading Inc. dba Woods.. | 9 10.47 90.70 Vi-Jon, Inc. | 1 1.16 91.86 VistaPharm, Inc. | 2 2.33 94.19 Xintec Corp | 1 1.16 95.35 Zimmer Biomet, Inc. | 1 1.16 96.51 Zydus Pharmaceuticals USA Inc | 3 3.49 100.00 ----------------------------------------+----------------------------------- Total | 86 100.00 Frequencies for address1 variable in enfrep20170809 dataset : Address1 | Freq. Percent Cum. ----------------------------+----------------------------------- 1 General Mills Blvd | 1 1.16 1.16 1 Swan Dr | 1 1.16 2.33 10165 McKellar Ct | 1 1.16 3.49 107 College Rd E | 1 1.16 4.65 1090 Horsham Rd | 2 2.33 6.98 12954 Fountain Run Rd | 2 2.33 9.30 14401 W 65th Way | 16 18.60 27.91 1451 66th St | 5 5.81 33.72 1660 S Loop Rd | 1 1.16 34.88 17070 Sonoma Highway | 1 1.16 36.05 1800 W Center St | 1 1.16 37.21 1990 Westwood Blvd Ste 135 | 1 1.16 38.37 221 Wheeling Rd | 2 2.33 40.70 23 Janis Way | 1 1.16 41.86 2300 Berkshire Ln N | 2 2.33 44.19 2399 E Busch Blvd | 5 5.81 50.00 2452 NE 51st Ave | 1 1.16 51.16 28 Chemin du petit Bois | 1 1.16 52.33 330 Franklin Tpke | 1 1.16 53.49 36 Columbia Rd | 3 3.49 56.98 4000 Northfield Way Ste 900 | 1 1.16 58.14 4285 N Wesleyan Blvd | 4 4.65 62.79 47900 Bayside Pkwy | 4 4.65 67.44 48 Woerd Ave | 1 1.16 68.60 50 Industrial Park Rd | 1 1.16 69.77 5400 Tech Data Dr | 1 1.16 70.93 5500 Lakeview Pkwy | 2 2.33 73.26 5550 Rosewood St | 1 1.16 74.42 6220 E Oak St | 1 1.16 75.58 677 Little Britain Rd | 1 1.16 76.74 7 Michael Ave | 1 1.16 77.91 7081 US Hwy 101 | 1 1.16 79.07 722 Progressive Ln | 1 1.16 80.23 7265 Ulmerton Rd | 2 2.33 82.56 727 N Ann Arbor Ave | 1 1.16 83.72 73 Route 31 N | 3 3.49 87.21 96 Executive Ave | 9 10.47 97.67 9965 Federal Drive | 1 1.16 98.84 Via Robert Koch 2 | 1 1.16 100.00 ----------------------------+----------------------------------- Total | 86 100.00 Frequencies for address2 variable in enfrep20170809 dataset : Address2 | Freq. Percent Cum. ------------+----------------------------------- . | 86 100.00 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for city variable in enfrep20170809 dataset : City | Freq. Percent Cum. -----------------+----------------------------------- Alameda | 1 1.16 1.16 Arvada | 16 18.60 19.77 Bay Center | 1 1.16 20.93 Clearwater | 1 1.16 22.09 Colorado Springs | 1 1.16 23.26 Davenport | 2 2.33 25.58 Ecully | 1 1.16 26.74 Edison | 9 10.47 37.21 Emeryville | 5 5.81 43.02 Farmingdale | 1 1.16 44.19 Fountain Run | 2 2.33 46.51 Fremont | 4 4.65 51.16 Lake Oswego | 1 1.16 52.33 Largo | 2 2.33 54.65 Lewistown | 1 1.16 55.81 Los Angeles | 1 1.16 56.98 Mahwah | 1 1.16 58.14 Milan | 1 1.16 59.30 Minneapolis | 1 1.16 60.47 Morristown | 3 3.49 63.95 New Windsor | 1 1.16 65.12 North Wales | 2 2.33 67.44 Oklahoma City | 1 1.16 68.60 Pennington | 3 3.49 72.09 Plymouth | 2 2.33 74.42 Portland | 1 1.16 75.58 Princeton | 1 1.16 76.74 Rocky Mount | 4 4.65 81.40 Roswell | 1 1.16 82.56 San Diego | 1 1.16 83.72 Scotts Valley | 1 1.16 84.88 Scottsdale | 1 1.16 86.05 Smyrna | 1 1.16 87.21 Sonoma | 1 1.16 88.37 South Beloit | 1 1.16 89.53 Waltham | 1 1.16 90.70 Warsaw | 1 1.16 91.86 Wheeling | 2 2.33 94.19 tampa | 5 5.81 100.00 -----------------+----------------------------------- Total | 86 100.00 Frequencies for stateprovince variable in enfrep20170809 dataset : State/Provi | nce | Freq. Percent Cum. ------------+----------------------------------- | 2 2.33 2.33 AZ | 1 1.16 3.49 CA | 14 16.28 19.77 CO | 17 19.77 39.53 FL | 8 9.30 48.84 GA | 1 1.16 50.00 IA | 2 2.33 52.33 IL | 3 3.49 55.81 IN | 1 1.16 56.98 KY | 2 2.33 59.30 MA | 1 1.16 60.47 MN | 3 3.49 63.95 NC | 4 4.65 68.60 NJ | 17 19.77 88.37 NY | 2 2.33 90.70 OK | 1 1.16 91.86 OR | 2 2.33 94.19 PA | 3 3.49 97.67 TN | 1 1.16 98.84 WA | 1 1.16 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for postalcode variable in enfrep20170809 dataset : Postal Code | Freq. Percent Cum. ------------+----------------------------------- | 2 2.33 2.33 02453-3824 | 1 1.16 3.49 07430-3524 | 1 1.16 4.65 07960-4526 | 3 3.49 8.14 08534-3601 | 3 3.49 11.63 08540-6623 | 1 1.16 12.79 08817-6016 | 9 10.47 23.26 11735-3921 | 1 1.16 24.42 12553-6152 | 1 1.16 25.58 17044-9312 | 1 1.16 26.74 19454-1505 | 2 2.33 29.07 27804-8612 | 4 4.65 33.72 30076-4955 | 1 1.16 34.88 33612-8407 | 5 5.81 40.70 33760-3116 | 1 1.16 41.86 33771-4809 | 2 2.33 44.19 37167-2099 | 1 1.16 45.35 42133-7914 | 2 2.33 47.67 46580-2304 | 1 1.16 48.84 52807-3481 | 2 2.33 51.16 55426-1347 | 1 1.16 52.33 55441-4575 | 2 2.33 54.65 60090-4809 | 2 2.33 56.98 61080-2616 | 1 1.16 58.14 73127-5822 | 1 1.16 59.30 80004-3503 | 16 18.60 77.91 80921-3617 | 1 1.16 79.07 85257-1101 | 1 1.16 80.23 90025-4650 | 1 1.16 81.40 92121-4201 | 1 1.16 82.56 94502-7091 | 1 1.16 83.72 94538-6515 | 4 4.65 88.37 94608-1004 | 5 5.81 94.19 95066-3506 | 1 1.16 95.35 95476 | 1 1.16 96.51 97035-5371 | 1 1.16 97.67 97213-2520 | 1 1.16 98.84 98527 | 1 1.16 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for country variable in enfrep20170809 dataset : Country | Freq. Percent Cum. --------------+----------------------------------- France | 1 1.16 1.16 Italy | 1 1.16 2.33 United States | 84 97.67 100.00 --------------+----------------------------------- Total | 86 100.00 Frequencies for voluntarymandated variable in enfrep20170809 dataset : Voluntary/Mandated | Freq. Percent Cum. --------------------------+----------------------------------- FDA Mandated | 2 2.33 2.33 Voluntary: Firm Initiated | 84 97.67 100.00 --------------------------+----------------------------------- Total | 86 100.00 Frequencies for initialfirmnotificationofconsign variable in enfrep20170809 dat Initial Firm Notification of Consignee | or Public | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 1 1.16 1.16 E-Mail | 13 15.12 16.28 FAX | 1 1.16 17.44 Letter | 30 34.88 52.33 Press Release | 4 4.65 56.98 Telephone | 19 22.09 79.07 Two or more of the following: Email, .. | 17 19.77 98.84 Visit | 1 1.16 100.00 ----------------------------------------+----------------------------------- Total | 86 100.00 Frequencies for distributionpattern variable in enfrep20170809 dataset : Distribution Pattern | Freq. Percent Cum. ----------------------------------------+----------------------------------- AR | 1 1.16 1.16 AZ, CA, FL, GA, HI, IL, IN, MA, MD, M.. | 2 2.33 3.49 Arizona | 1 1.16 4.65 CA | 1 1.16 5.81 CA only | 1 1.16 6.98 CA, CO, OR, WA | 1 1.16 8.14 CA, IL, LA, NH, OH, PA, SC | 2 2.33 10.47 CA, MN, WA, IL, PR, ME, SD. | 1 1.16 11.63 California; Switzerland | 2 2.33 13.95 GA, PA, NJ | 1 1.16 15.12 KY | 2 2.33 17.44 NY | 1 1.16 18.60 Nationwide | 24 27.91 46.51 Nationwide Distribution | 1 1.16 47.67 Nationwide Distribution including AR,.. | 1 1.16 48.84 Nationwide U.S.A. | 1 1.16 50.00 Nationwide in the USA | 1 1.16 51.16 Nationwide in the USA and Puerto Rico | 1 1.16 52.33 Nationwide. distribution and to Unite.. | 5 5.81 58.14 New York, New Jersey, Connecticut | 1 1.16 59.30 OH and CT | 1 1.16 60.47 The products were shipped to retailer.. | 9 10.47 70.93 There were only one customer in Calif.. | 1 1.16 72.09 U.S. (including Puerto Rico), Dutch A.. | 4 4.65 76.74 US Distribution to states of: CA, IL,.. | 1 1.16 77.91 US Distribution to the states of : AL.. | 1 1.16 79.07 US consignees only. | 5 5.81 84.88 US distribution to MD, NY & PA | 1 1.16 86.05 Worldwide Diribution - US including T.. | 1 1.16 87.21 Worldwide Distribution - US Distribut.. | 1 1.16 88.37 Worldwide Distribution - US including.. | 1 1.16 89.53 Worldwide Distribution - US including.. | 1 1.16 90.70 Worldwide Distribution - USA (nationw.. | 1 1.16 91.86 Worldwide distribution- US (Nationwid.. | 1 1.16 93.02 distributed in AZ, CA, CO, CT, FL, GA.. | 1 1.16 94.19 distributed in AZ, CA, ID, OR, TX, an.. | 1 1.16 95.35 nationwide | 4 4.65 100.00 ----------------------------------------+----------------------------------- Total | 86 100.00 Frequencies for recallnumber variable in enfrep20170809 dataset : Recall | Number | Freq. Percent Cum. ------------+----------------------------------- B-0770-2017 | 1 1.16 1.16 B-0771-2017 | 1 1.16 2.33 B-0772-2017 | 1 1.16 3.49 D-1035-2017 | 1 1.16 4.65 D-1036-2017 | 1 1.16 5.81 D-1037-2017 | 1 1.16 6.98 D-1038-2017 | 1 1.16 8.14 D-1039-2017 | 1 1.16 9.30 D-1040-2017 | 1 1.16 10.47 D-1041-2017 | 1 1.16 11.63 D-1042-2017 | 1 1.16 12.79 D-1043-2017 | 1 1.16 13.95 D-1044-2017 | 1 1.16 15.12 D-1046-2017 | 1 1.16 16.28 D-1047-2017 | 1 1.16 17.44 D-1048-2017 | 1 1.16 18.60 D-1049-2017 | 1 1.16 19.77 D-1050-2017 | 1 1.16 20.93 D-1051-2017 | 1 1.16 22.09 D-1052-2017 | 1 1.16 23.26 D-1053-2017 | 1 1.16 24.42 D-1054-2017 | 1 1.16 25.58 D-1055-2017 | 1 1.16 26.74 D-1056-2017 | 1 1.16 27.91 D-1057-2017 | 1 1.16 29.07 F-2953-2017 | 1 1.16 30.23 F-2954-2017 | 1 1.16 31.40 F-2955-2017 | 1 1.16 32.56 F-2956-2017 | 1 1.16 33.72 F-2957-2017 | 1 1.16 34.88 F-2958-2017 | 1 1.16 36.05 F-2959-2017 | 1 1.16 37.21 F-2960-2017 | 1 1.16 38.37 F-2961-2017 | 1 1.16 39.53 F-2962-2017 | 1 1.16 40.70 F-2963-2017 | 1 1.16 41.86 F-2964-2017 | 1 1.16 43.02 F-3336-2017 | 1 1.16 44.19 F-3338-2017 | 1 1.16 45.35 F-3339-2017 | 1 1.16 46.51 F-3340-2017 | 1 1.16 47.67 F-3341-2017 | 1 1.16 48.84 F-3342-2017 | 1 1.16 50.00 F-3343-2017 | 1 1.16 51.16 F-3344-2017 | 1 1.16 52.33 F-3345-2017 | 1 1.16 53.49 F-3346-2017 | 1 1.16 54.65 F-3347-2017 | 1 1.16 55.81 F-3348-2017 | 1 1.16 56.98 F-3349-2017 | 1 1.16 58.14 V-0273-2017 | 1 1.16 59.30 V-0274-2017 | 1 1.16 60.47 V-0275-2017 | 1 1.16 61.63 Z-2760-2017 | 1 1.16 62.79 Z-2777-2017 | 1 1.16 63.95 Z-2779-2017 | 1 1.16 65.12 Z-2780-2017 | 1 1.16 66.28 Z-2781-2017 | 1 1.16 67.44 Z-2782-2017 | 1 1.16 68.60 Z-2783-2017 | 1 1.16 69.77 Z-2784-2017 | 1 1.16 70.93 Z-2785-2017 | 1 1.16 72.09 Z-2786-2017 | 1 1.16 73.26 Z-2787-2017 | 1 1.16 74.42 Z-2788-2017 | 1 1.16 75.58 Z-2789-2017 | 1 1.16 76.74 Z-2790-2017 | 1 1.16 77.91 Z-2791-2017 | 1 1.16 79.07 Z-2792-2017 | 1 1.16 80.23 Z-2793-2017 | 1 1.16 81.40 Z-2794-2017 | 1 1.16 82.56 Z-2795-2017 | 1 1.16 83.72 Z-2796-2017 | 1 1.16 84.88 Z-2797-2017 | 1 1.16 86.05 Z-2798-2017 | 1 1.16 87.21 Z-2799-2017 | 1 1.16 88.37 Z-2800-2017 | 1 1.16 89.53 Z-2801-2017 | 1 1.16 90.70 Z-2802-2017 | 1 1.16 91.86 Z-2803-2017 | 1 1.16 93.02 Z-2863-2017 | 1 1.16 94.19 Z-2865-2017 | 1 1.16 95.35 Z-2866-2017 | 1 1.16 96.51 Z-2867-2017 | 1 1.16 97.67 Z-2868-2017 | 1 1.16 98.84 Z-2869-2017 | 1 1.16 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for classification variable in enfrep20170809 dataset : Classificat | ion | Freq. Percent Cum. ------------+----------------------------------- Class I | 19 22.09 22.09 Class II | 65 75.58 97.67 Class III | 2 2.33 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for productdescription variable in enfrep20170809 dataset : Product Description | Freq. Percent Cum. ----------------------------------------+----------------------------------- PEDS PACK, REF 627262502, STERILE EO.. | 1 1.16 1.16 PEDS PACK, REF 627263601, STERILE EO.. | 1 1.16 2.33 plate in PEEK and NE0411 screws in T.. | 1 1.16 3.49 . | 2 2.33 5.81 8.4% Sodium Bicarbonate Inj., USP 50 .. | 1 1.16 6.98 Albuterol Sulfate Inhalation Solution.. | 1 1.16 8.14 Alka-Seltzer Gold (1000 mg Anhydrous.. | 1 1.16 9.30 Alka-Seltzer Extra Strength (500 mg A.. | 1 1.16 10.47 Alka-Seltzer Original ( 325 mg Aspiri.. | 1 1.16 11.63 Amantadine HCl Capsules, USP, 100 mg,.. | 1 1.16 12.79 Biosense Webster MobiCath Bi-Directio.. | 1 1.16 13.95 Black Beans Bonanza Tamales with blac.. | 1 1.16 15.12 Blood and Blood Products for Reproces.. | 1 1.16 16.28 Carbamazepine Oral Suspension, USP. 1.. | 1 1.16 17.44 Clif Builders Chocolate Mint 12-coun.. | 1 1.16 18.60 Clif Builders Variety Pack Chocolate .. | 1 1.16 19.77 Clif Kid Zbar Protein Chocolate Chip .. | 1 1.16 20.93 Clif Kid Zbar Protein Chocolate Mint .. | 1 1.16 22.09 Clif Kid Zbar Protein Variety Pack 3.. | 1 1.16 23.26 Cyclobenzaprine HCl Tablets, USP, 5 m.. | 1 1.16 24.42 Divalproex Sodium Delayed Release Tab.. | 1 1.16 25.58 Divalproex Sodium Delayed Release Tab.. | 1 1.16 26.74 Divalproex Sodium Delayed Release Tab.. | 1 1.16 27.91 Evanger's Hand Packed Braised Beef Ch.. | 1 1.16 29.07 Evanger's Hand Packed Hunk of Beef Au.. | 1 1.16 30.23 Famotidine Tablets USP, 20 mg, 100 co.. | 1 1.16 31.40 Famotidine USP 20 mg, 30 tablets bott.. | 1 1.16 32.56 GE Inspection Technologies Blade|line.. | 1 1.16 33.72 IQF White Rice ES CA, Cardboard Tote,.. | 1 1.16 34.88 Ibuprofen Tablets, USP 600 mg, 500-co.. | 1 1.16 36.05 InflammaDry(R) AN RPS DIAGNOSTIC SOLU.. | 1 1.16 37.21 Lactulose Solution, USP, 10 g/15 mL, .. | 1 1.16 38.37 Lactulose Solution, USP, 20 g/30 mL, .. | 1 1.16 39.53 MULTIGENT Creatinine (Enzymatic), Cat.. | 1 1.16 40.70 Magnesium Citrate Oral Solution, pack.. | 1 1.16 41.86 Market Basket Cape Cod Cranberry Mix .. | 1 1.16 43.02 Market Basket Cascade Trail Mix 11oz. | 1 1.16 44.19 Market Basket Fiber Frenzy 10oz. | 1 1.16 45.35 Myelotec Video Guided Catheters, REF.. | 1 1.16 46.51 NON-STERILE SAMPLE, SORIN GROUP, SMAR.. | 1 1.16 47.67 NON-STERILE SAMPLE, SORIN GROUP, SMAR.. | 1 1.16 48.84 NON-STERILE SAMPLE, SORIN GROUP, SMAR.. | 1 1.16 50.00 Natures Promise Organic Campfire Tra.. | 1 1.16 51.16 Natures Promise Cascade Trail Mix 12oz. | 1 1.16 52.33 Natures Promise Cranberry Trail Mix 1.. | 1 1.16 53.49 Neut Sodium Bicarbonate 4% (2.4 mEq) .. | 1 1.16 54.65 Olympus Scientific Solutions Americas.. | 1 1.16 55.81 OptiLITE(TM) Products for Laser Surge.. | 1 1.16 56.98 Oxford/Oxbridge AFN End Cap 10 mm x.. | 1 1.16 58.14 Planetary Herbals Ginseng Classic; C.. | 1 1.16 59.30 Pooled Cryoprecipitated AHF | 1 1.16 60.47 Potassium Phosphates Inj., USP, 45 mM.. | 1 1.16 61.63 Pravastatin Sodium Tablets, USP, 10 m.. | 1 1.16 62.79 Professional Formulas Sublinqual B12 .. | 1 1.16 63.95 ROSA Brain, 3.0.0 The device is inte.. | 1 1.16 65.12 Red Blood Cells, Leukocytes Reduced | 1 1.16 66.28 SAMI'S BAKERY, BAKLAVA WALNUT, Net We.. | 1 1.16 67.44 SAMI'S BAKERY, Date Almond Cookies, N.. | 1 1.16 68.60 SAMI'S BAKERY, Oatmeal Raisin Cookies.. | 1 1.16 69.77 SAMI'S BAKERY, Peanut Butter Cookies,.. | 1 1.16 70.93 SAMI'S BAKERY, Walnut Chocolate Chip .. | 1 1.16 72.09 SORIN GROUP, SMART PERFUSION PACK, IN.. | 1 1.16 73.26 SORIN GROUP, SMART PERFUSION PACK, IN.. | 1 1.16 74.42 SORIN GROUP, SMART PERFUSION PACK, IN.. | 1 1.16 75.58 SORIN GROUP, SMART PERFUSION PACK, LO.. | 1 1.16 76.74 SORIN GROUP, SMART PERFUSION PACK, NE.. | 1 1.16 77.91 SORIN GROUP, SMART PERFUSION PACK, PU.. | 1 1.16 79.07 SORIN GROUP, SMART PERFUSION PACK, SM.. | 1 1.16 80.23 SORIN GROUP, SMART PERFUSION PACK, SM.. | 1 1.16 81.40 SORIN GROUP, SMART PERFUSION PACK, SM.. | 1 1.16 82.56 SORIN GROUP, SMART PERFUSION PACK, TO.. | 1 1.16 83.72 STERILE SAMPLE SORIN GROUP, SMART PER.. | 1 1.16 84.88 SoftLab Software Laboratory inform.. | 1 1.16 86.05 Spectranetics Turbo-Elite Laser Ather.. | 1 1.16 87.21 Stroke Fast Pack(TM) Trevo XP ProVue .. | 1 1.16 88.37 Stroke Fast Pack(TM) Trevo XP ProVue .. | 1 1.16 89.53 Stroke Fast Pack(TM) Trevo XP ProVue .. | 1 1.16 90.70 Stroke Fast Pack(TM) Trevo XP ProVue .. | 1 1.16 91.86 Succinylcholine Chloride Injection, U.. | 1 1.16 93.02 Testosterone Cypionate + Progesterone.. | 1 1.16 94.19 ViaPeel PTFE Peelable Introducer 5FR,.. | 1 1.16 95.35 Whole Foods Market Thai Shrimp Salad,.. | 1 1.16 96.51 Wholesome Pantry Cape Cod Cranberry M.. | 1 1.16 97.67 Wholesome Pantry Organic Trail Mix 8oz. | 1 1.16 98.84 Woodstock Organic Kumbaya Mix 10oz. | 1 1.16 100.00 ----------------------------------------+----------------------------------- Total | 86 100.00 Frequencies for productquantity variable in enfrep20170809 dataset : Product Quantity | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 2 2.33 2.33 1 unit | 8 9.30 11.63 1,067,520 12-count cartons | 1 1.16 12.79 1,483 cartons | 1 1.16 13.95 1,719 cases (12 cans per case) | 1 1.16 15.12 1,980 bottles | 1 1.16 16.28 100 bottles | 1 1.16 17.44 100,685,754 total | 5 5.81 23.26 101,244 bottles | 1 1.16 24.42 1078 kits, 21,560 sample collectors | 1 1.16 25.58 108,096 HDPE bottles | 1 1.16 26.74 108,726 HDPE bottles | 1 1.16 27.91 11,360 | 1 1.16 29.07 115,122 HDPE bottles | 1 1.16 30.23 120 vials | 1 1.16 31.40 13 units distributed in the US | 1 1.16 32.56 1350 lbs (1 tote) | 1 1.16 33.72 139 packs | 1 1.16 34.88 146 units | 1 1.16 36.05 15,034,600 10 mL multiple dose use vi.. | 1 1.16 37.21 18 units | 1 1.16 38.37 20 units (16 US, 4 OUS) | 1 1.16 39.53 20,337,650 15 mL single dose vials | 1 1.16 40.70 208 Cases | 1 1.16 41.86 21,436,700 5mL single dose vials | 1 1.16 43.02 214 Cases | 1 1.16 44.19 2178/60 tablets Bottles | 1 1.16 45.35 2356 kits Worldwide; US 206 kits | 1 1.16 46.51 238 Cases | 1 1.16 47.67 24,672 24-count cartons | 1 1.16 48.84 240 packages (4 tamales per package) | 1 1.16 50.00 25 cases (100 units) | 1 1.16 51.16 277 units | 1 1.16 52.33 28,188 bottles | 1 1.16 53.49 282 cases (15/2 lb. packages) | 1 1.16 54.65 287 screws | 1 1.16 55.81 2980 units | 1 1.16 56.98 3,165 cases (12 cans per case) | 1 1.16 58.14 32 units | 1 1.16 59.30 36 bottles - 7 x 120 count and 29 x .. | 1 1.16 60.47 376 Cases | 1 1.16 61.63 4 units | 1 1.16 62.79 401,750 cartons | 1 1.16 63.95 43 packs | 1 1.16 65.12 4343 units | 1 1.16 66.28 4610 cases (12/1 lb. packages per case) | 1 1.16 67.44 471 Cases | 1 1.16 68.60 48 units | 1 1.16 69.77 480 (5mL) unit dose cups | 1 1.16 70.93 491 Cases | 1 1.16 72.09 5 units | 1 1.16 73.26 5,000 devices | 1 1.16 74.42 50 units | 1 1.16 75.58 52 units | 1 1.16 76.74 524 units | 1 1.16 77.91 54 units | 1 1.16 79.07 544 bottles | 1 1.16 80.23 56,064 36-count cartons | 1 1.16 81.40 6150 cases | 1 1.16 82.56 63 packs | 1 1.16 83.72 632 units | 1 1.16 84.88 66 Cases | 1 1.16 86.05 71 Cases | 2 2.33 88.37 733 units | 1 1.16 89.53 8 units | 1 1.16 90.70 91,483,150 50 mL single dose vials | 1 1.16 91.86 98 units | 1 1.16 93.02 9945 cases | 1 1.16 94.19 unknown | 5 5.81 100.00 ----------------------------------------+----------------------------------- Total | 86 100.00 Frequencies for reasonforrecall variable in enfrep20170809 dataset : Reason for Recall | Freq. Percent Cum. ----------------------------------------+----------------------------------- Blood product in which routine testin.. | 1 1.16 1.16 Blood products, collected from a dono.. | 2 2.33 3.49 CGMP Deviations | 1 1.16 4.65 Complaint of the head holder connecto.. | 1 1.16 5.81 Defective Container: Confirmed custom.. | 3 3.49 9.30 Display of lab results based on incor.. | 1 1.16 10.47 Failed Dissolution Specifications | 3 3.49 13.95 Failed Impurities/Degradation Specifi.. | 1 1.16 15.12 Failed Impurities/Degradation Specifi.. | 1 1.16 16.28 Failed Tablet/Capsule Specification: .. | 1 1.16 17.44 Failed Tablet/Capsule Specification; .. | 1 1.16 18.60 GE Inspection Technologies, LP determ.. | 1 1.16 19.77 General Mills was notified by custome.. | 1 1.16 20.93 Greatbatch received complaints with t.. | 1 1.16 22.09 In-house testing revealed the presenc.. | 1 1.16 23.26 Instruments may, under certain specif.. | 1 1.16 24.42 It has been determined that the repro.. | 1 1.16 25.58 Labeling Error: Label mix-up. Produc.. | 1 1.16 26.74 Labeling; Label Mix up; cartons label.. | 2 2.33 29.07 Lack of Sterility Assurance | 4 4.65 33.72 Medtronic informed LivaNova that some.. | 16 18.60 52.33 Microbial contamination of non-steril.. | 2 2.33 54.65 Microbial contamination of non-steril.. | 1 1.16 55.81 Obstructed/blocked port from defectiv.. | 1 1.16 56.98 One side of the MobiCath Bi-Direction.. | 1 1.16 58.14 Potential for flouroscopially visible.. | 1 1.16 59.30 Presence of foreign tablets/capsules.. | 1 1.16 60.47 Product is potentially contaminated w.. | 2 2.33 62.79 Product was inadvertently released pr.. | 1 1.16 63.95 Reagent 1 component may result in Qua.. | 1 1.16 65.12 Stryker Neurovascular has become awar.. | 4 4.65 69.77 Sublinqual B12 tablets are recalled b.. | 1 1.16 70.93 Thai Shrimp Salad has incorrect back.. | 1 1.16 72.09 The Smallbatch brand, frozen chicken .. | 1 1.16 73.26 The firm received several customer co.. | 1 1.16 74.42 The firm's supplier (of dates/apricot.. | 9 10.47 84.88 There is a material mislabeling of th.. | 1 1.16 86.05 Undeclared allergen: Milk | 5 5.81 91.86 Undeclared milk. Goose Point Steamers.. | 1 1.16 93.02 Undeclared peanuts and/or tree nuts. | 5 5.81 98.84 the product contains undeclared milk .. | 1 1.16 100.00 ----------------------------------------+----------------------------------- Total | 86 100.00 Frequencies for centerclassificationdate variable in enfrep20170809 dataset : Center | Classificat | ion Date | Freq. Percent Cum. ------------+----------------------------------- 07/28/2017 | 3 3.49 3.49 07/29/2017 | 22 25.58 29.07 07/31/2017 | 14 16.28 45.35 08/01/2017 | 12 13.95 59.30 08/02/2017 | 14 16.28 75.58 08/03/2017 | 21 24.42 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for terminationdate variable in enfrep20170809 dataset : Termination | Date | Freq. Percent Cum. ------------+----------------------------------- | 81 94.19 94.19 08/02/2017 | 4 4.65 98.84 08/07/2017 | 1 1.16 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for codeinfo variable in enfrep20170809 dataset : Code Info | Freq. Percent Cum. ----------------------------------------+----------------------------------- The last three digits represent the .. | 1 1.16 1.16 22APR7BV | 1 1.16 2.33 60 count lot FG-86688, Exp. 5/21; 12.. | 1 1.16 3.49 All batch numbers | 1 1.16 4.65 All product manufactured between Dece.. | 1 1.16 5.81 All product manufactured between Dece.. | 1 1.16 6.98 BTAH340; Exp. 02/19 BTAHCP0; Exp. 04.. | 1 1.16 8.14 BTAHDG0; Exp. 04/19 | 1 1.16 9.30 BTAHGR0; Exp. 05/19 BTAHGR1; Exp. 05.. | 1 1.16 10.47 Catalog Number 8L24-31: Lot Numbers: .. | 1 1.16 11.63 Device Listing No. D264591, Serial No.. | 1 1.16 12.79 Item Code OS331107 S1009023 Mar-2.. | 1 1.16 13.95 Lot # 03022017+44906; BUD 08/29/17 | 1 1.16 15.12 Lot # 17096, 17124, 17100 UPC # 0425.. | 1 1.16 16.28 Lot # 17100, 17115 / UPC # 688267066092 | 1 1.16 17.44 Lot # 17132, UPC # 049705408322 | 1 1.16 18.60 Lot # 17138 UPC # 688267066122 | 1 1.16 19.77 Lot # 17142, UPC # 041190054855 | 1 1.16 20.93 Lot # 17142, 17160 UPC # 041190054992.. | 1 1.16 22.09 Lot # 17150, UPC # 049705409107 | 1 1.16 23.26 Lot # 17156, UPC # 049705408377 | 1 1.16 24.42 Lot # 17158 UPC # 688267066160 | 1 1.16 25.58 Lot # 3429066, exp 06/2018 | 1 1.16 26.74 Lot #: 458300, Exp 09/2018; 462600, E.. | 1 1.16 27.91 Lot #: 468300, Exp 09/2018; 474400, E.. | 1 1.16 29.07 Lot #: 500326, Exp. 6/30/2018 | 1 1.16 30.23 Lot #: HN7003 | 1 1.16 31.40 Lot #: a) C700220, Exp 06/18; b) C700.. | 1 1.16 32.56 Lot #s: GA60206, GA60207, Exp 08/17; .. | 1 1.16 33.72 Lot Code From 05APR16M3 to 23APR18M3 | 3 3.49 37.21 Lot Code From 24MAR16M to 08FEB18M | 1 1.16 38.37 Lot Code From 31MAY16M to 15OCT17M | 1 1.16 39.53 Lot D032, Best by 2/1/2018 Lot E058,.. | 1 1.16 40.70 Lot No. 4123/MY33613, 4250/MY06614, 4.. | 1 1.16 41.86 Lot Number 1623100001 | 1 1.16 43.02 Lot Number 1627300090 | 1 1.16 44.19 Lot Number 1703300074 | 1 1.16 45.35 Lot Number 1703700067 | 1 1.16 46.51 Lot Number 1709500117 | 1 1.16 47.67 Lot Number 1717300032 | 1 1.16 48.84 Lot Number: W3101005 | 1 1.16 50.00 Lot Number: 11917 Expiration Date: 0.. | 1 1.16 51.16 Lot Numbers: (a) 1703100033, 1703200.. | 1 1.16 52.33 Lot Numbers: 1620000113, 1622400049,.. | 1 1.16 53.49 Lot Numbers: 1620000123, 1622800056,.. | 1 1.16 54.65 Lot Numbers: 1620700048, 1621600063,.. | 1 1.16 55.81 Lot Numbers: 1621400045, 1628600043 | 1 1.16 56.98 Lot Numbers: 1621400046, 1623100048,.. | 1 1.16 58.14 Lot Numbers: 1622100055, 1625200039,.. | 1 1.16 59.30 Lot Numbers: 1625200040, 1635400048,.. | 1 1.16 60.47 Lot Numbers: 1626400126, 1628100032,.. | 1 1.16 61.63 Lot Numbers: QPC20107530, QPC20107745.. | 1 1.16 62.79 Lot Numbers: QPC30107530, QPC30107745.. | 1 1.16 63.95 Lot Numbers: QPC40107530, QPC40107745.. | 1 1.16 65.12 Lot Numbers: QXC10107745, QXC10107814.. | 1 1.16 66.28 Lot codes: AJT28AUG2017 AJT32AU.. | 1 1.16 67.44 Lot numbers: 1620200038, 1621700037,.. | 1 1.16 68.60 Lot numbers: 1705405, 1705359 | 1 1.16 69.77 Lot#: a) 0341906, Exp 12/2018; b) 034.. | 1 1.16 70.93 Lot: 16710, exp 07/2018 | 2 2.33 73.26 Lot: 72109EV Exp. 12/01/2018, Lot: 72.. | 1 1.16 74.42 Lot: 74119EV Exp. 02/01/2019 Lot: 74.. | 1 1.16 75.58 Lot: A17F55 Exp. 06/30/2018 | 1 1.16 76.74 M603084 May-18 M603085 May-18 M6036.. | 1 1.16 77.91 MR5990 May-17 MR5991 May-17 MR7294 .. | 1 1.16 79.07 MR6317 Exp.05/17 MR6318 Exp. 05/17 .. | 1 1.16 80.23 Model D140010, Lots: W3332609, W3338.. | 1 1.16 81.40 Model Number 414-159 Catheter Diamete.. | 1 1.16 82.56 Models : VCR and VMR. | 1 1.16 83.72 No lot codes: Expiry Date 7/3/17. | 1 1.16 84.88 Serial No. TM 201317 TM 201312 .. | 1 1.16 86.05 Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.. | 1 1.16 87.21 W041017082866D | 1 1.16 88.37 W333617023003 | 1 1.16 89.53 W333617031386 | 1 1.16 90.70 a.) one vial Lot: 74393EV Exp. 05/.. | 1 1.16 91.86 a.) one vial: Lot: 72226EV Exp. 12.. | 1 1.16 93.02 all codes. | 1 1.16 94.19 none reported | 5 5.81 100.00 ----------------------------------------+----------------------------------- Total | 86 100.00 Frequencies for recallinitiationdate variable in enfrep20170809 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 11oct2016 | 1 1.16 1.16 11nov2016 | 1 1.16 2.33 03feb2017 | 2 2.33 4.65 15feb2017 | 1 1.16 5.81 02mar2017 | 1 1.16 6.98 30mar2017 | 3 3.49 10.47 19apr2017 | 1 1.16 11.63 03may2017 | 1 1.16 12.79 10may2017 | 3 3.49 16.28 22may2017 | 1 1.16 17.44 31may2017 | 1 1.16 18.60 06jun2017 | 1 1.16 19.77 14jun2017 | 2 2.33 22.09 15jun2017 | 13 15.12 37.21 16jun2017 | 3 3.49 40.70 19jun2017 | 2 2.33 43.02 22jun2017 | 6 6.98 50.00 23jun2017 | 1 1.16 51.16 26jun2017 | 6 6.98 58.14 27jun2017 | 1 1.16 59.30 28jun2017 | 1 1.16 60.47 29jun2017 | 16 18.60 79.07 03jul2017 | 1 1.16 80.23 05jul2017 | 6 6.98 87.21 11jul2017 | 2 2.33 89.53 12jul2017 | 1 1.16 90.70 13jul2017 | 2 2.33 93.02 17jul2017 | 1 1.16 94.19 19jul2017 | 1 1.16 95.35 21jul2017 | 1 1.16 96.51 24jul2017 | 1 1.16 97.67 25jul2017 | 1 1.16 98.84 28jul2017 | 1 1.16 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for recallinitiationdatestr variable in enfrep20170809 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 02/03/2017 | 2 2.33 2.33 02/15/2017 | 1 1.16 3.49 03/02/2017 | 1 1.16 4.65 03/30/2017 | 3 3.49 8.14 04/19/2017 | 1 1.16 9.30 05/03/2017 | 1 1.16 10.47 05/10/2017 | 3 3.49 13.95 05/22/2017 | 1 1.16 15.12 05/31/2017 | 1 1.16 16.28 06/06/2017 | 1 1.16 17.44 06/14/2017 | 2 2.33 19.77 06/15/2017 | 13 15.12 34.88 06/16/2017 | 3 3.49 38.37 06/19/2017 | 2 2.33 40.70 06/22/2017 | 6 6.98 47.67 06/23/2017 | 1 1.16 48.84 06/26/2017 | 6 6.98 55.81 06/27/2017 | 1 1.16 56.98 06/28/2017 | 1 1.16 58.14 06/29/2017 | 16 18.60 76.74 07/03/2017 | 1 1.16 77.91 07/05/2017 | 6 6.98 84.88 07/11/2017 | 2 2.33 87.21 07/12/2017 | 1 1.16 88.37 07/13/2017 | 2 2.33 90.70 07/17/2017 | 1 1.16 91.86 07/19/2017 | 1 1.16 93.02 07/21/2017 | 1 1.16 94.19 07/24/2017 | 1 1.16 95.35 07/25/2017 | 1 1.16 96.51 07/28/2017 | 1 1.16 97.67 10/11/2016 | 1 1.16 98.84 11/11/2016 | 1 1.16 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for reportdate variable in enfrep20170809 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 09aug2017 | 86 100.00 100.00 ------------+----------------------------------- Total | 86 100.00 Frequencies for reportdatestr variable in enfrep20170809 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 08/09/2017 | 86 100.00 100.00 ------------+----------------------------------- Total | 86 100.00 by Jean Roth , jroth@nber.org , 10 Aug 2017