Frequencies for enfrep20170222 dataset : by Jean Roth , jroth@nber.org , 23 Feb 2017 Frequencies for producttype variable in enfrep20170222 dataset : Product | Type | Freq. Percent Cum. ------------+----------------------------------- Biologics | 13 17.11 17.11 Devices | 39 51.32 68.42 Drugs | 7 9.21 77.63 Food | 17 22.37 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for eventid variable in enfrep20170222 dataset : Event ID | Freq. Percent Cum. ------------+----------------------------------- 69986 | 2 2.63 2.63 75616 | 1 1.32 3.95 75707 | 7 9.21 13.16 75753 | 1 1.32 14.47 75929 | 1 1.32 15.79 75942 | 1 1.32 17.11 75971 | 1 1.32 18.42 76025 | 1 1.32 19.74 76105 | 1 1.32 21.05 76138 | 2 2.63 23.68 76157 | 8 10.53 34.21 76160 | 1 1.32 35.53 76164 | 1 1.32 36.84 76178 | 1 1.32 38.16 76183 | 2 2.63 40.79 76194 | 1 1.32 42.11 76209 | 1 1.32 43.42 76210 | 1 1.32 44.74 76236 | 1 1.32 46.05 76257 | 1 1.32 47.37 76259 | 1 1.32 48.68 76262 | 1 1.32 50.00 76281 | 1 1.32 51.32 76288 | 1 1.32 52.63 76290 | 1 1.32 53.95 76292 | 3 3.95 57.89 76293 | 2 2.63 60.53 76295 | 1 1.32 61.84 76320 | 1 1.32 63.16 76325 | 1 1.32 64.47 76332 | 1 1.32 65.79 76344 | 1 1.32 67.11 76348 | 2 2.63 69.74 76349 | 1 1.32 71.05 76350 | 1 1.32 72.37 76370 | 1 1.32 73.68 76375 | 1 1.32 75.00 76378 | 1 1.32 76.32 76383 | 1 1.32 77.63 76398 | 10 13.16 90.79 76406 | 1 1.32 92.11 76448 | 1 1.32 93.42 76454 | 4 5.26 98.68 76455 | 1 1.32 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for status variable in enfrep20170222 dataset : Status | Freq. Percent Cum. ------------+----------------------------------- Completed | 1 1.32 1.32 Ongoing | 59 77.63 78.95 Terminated | 16 21.05 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for recallingfirm variable in enfrep20170222 dataset : Recalling Firm | Freq. Percent Cum. ----------------------------------------+----------------------------------- Abbott Vascular | 1 1.32 1.32 Accord Healthcare, Inc. | 1 1.32 2.63 Actavis Inc | 1 1.32 3.95 Acumed LLC | 1 1.32 5.26 Advanced Sterilization Products | 1 1.32 6.58 Aesculap Implant Systems LLC | 1 1.32 7.89 Allen Medical Systems, Inc. | 1 1.32 9.21 Argon Medical Devices, Inc | 3 3.95 13.16 Atrium Medical Corporation | 9 11.84 25.00 Aurobindo Pharma USA Inc | 1 1.32 26.32 Becton Dickinson & Company | 1 1.32 27.63 BioMerieux SA | 1 1.32 28.95 Bwi Inc | 1 1.32 30.26 Carter BloodCare | 10 13.16 43.42 Crystal Geyser Water Company | 1 1.32 44.74 Encore Medical, Lp | 1 1.32 46.05 GE Healthcare, LLC | 1 1.32 47.37 Giant Eagle, Inc. | 2 2.63 50.00 Greatbatch Medical | 1 1.32 51.32 Integra LifeSciences Corp. | 1 1.32 52.63 Jersey Shore Supplements, LLC | 1 1.32 53.95 KEDPlasma, LLC | 1 1.32 55.26 LEO PHARMA INC | 1 1.32 56.58 MS Bionic | 1 1.32 57.89 Mako Surgical Corporation | 1 1.32 59.21 Merge Healthcare, Inc. | 1 1.32 60.53 NOW Foods | 1 1.32 61.84 New York Blood Center, Inc. | 2 2.63 64.47 Philips Medical Systems (Cleveland) Inc | 2 2.63 67.11 Physio-Control, Inc. | 1 1.32 68.42 Pier Fish Company, Inc. | 1 1.32 69.74 Siemens Healthcare Diagnostics, Inc. | 3 3.95 73.68 Siemens Medical Solutions USA, Inc | 4 5.26 78.95 Terumo Cardiovascular Systems Corpora.. | 1 1.32 80.26 Teva Pharmaceuticals USA | 1 1.32 81.58 The Pictsweet Company | 1 1.32 82.89 The Two Little Guys Company | 1 1.32 84.21 Whole Foods Market Brand 365, Llc | 8 10.53 94.74 Yum Retaurants International | 1 1.32 96.05 Zimmer Biomet, Inc. | 3 3.95 100.00 ----------------------------------------+----------------------------------- Total | 76 100.00 Frequencies for address1 variable in enfrep20170222 dataset : Address1 | Freq. Percent Cum. --------------------------+----------------------------------- #10 Pictsweet Drive | 1 1.32 1.32 1 Becton Dr | 1 1.32 2.63 1009 Slater Rd Ste 210B | 1 1.32 3.95 101 Kappa Dr | 2 2.63 6.58 1090 Horsham Rd | 1 1.32 7.89 11811 Willows Rd NE | 1 1.32 9.21 125 Blue Ball Rd | 1 1.32 10.53 1445 Flat Creek Rd | 3 3.95 14.47 2205 Highway 121 | 10 13.16 27.63 2300 Berkshire Ln N | 1 1.32 28.95 250 YWCA Way | 1 1.32 30.26 2555 Davie Rd Ste 110 | 1 1.32 31.58 26531 Ynez Rd | 1 1.32 32.89 3000 N Grandview Blvd | 1 1.32 34.21 310 E 67th St | 2 2.63 36.84 311 Enterprise Dr | 1 1.32 38.16 33 Technology Dr | 1 1.32 39.47 3773 Corporate Pkwy | 1 1.32 40.79 395 Glen Ellyn Rd | 1 1.32 42.11 40 Liberty Blvd | 4 5.26 47.37 400 Interpace Pkwy | 1 1.32 48.68 447 E Gardena Blvd | 1 1.32 50.00 5 Wentworth Dr | 9 11.84 61.84 500 Gbc Dr Ms 514 | 2 2.63 64.47 501 Washington St | 1 1.32 65.79 511 Benedict Ave | 1 1.32 67.11 56 E Bell Dr | 3 3.95 71.05 5711 Corsa Ave | 1 1.32 72.37 5885 NW Cornelius Pass Rd | 1 1.32 73.68 595 Miner Rd | 2 2.63 76.32 601 N Lamar Blvd Ste 300 | 8 10.53 86.84 666 Plainsboro Rd Ste 210 | 1 1.32 88.16 68 Conway St | 1 1.32 89.47 7 Giralda Farms | 1 1.32 90.79 705 Brinley Ave | 1 1.32 92.11 7100 Corporate Dr | 1 1.32 93.42 900 Walnut Ridge Dr | 1 1.32 94.74 9800 Metric Blvd | 1 1.32 96.05 Chemin De L'Orme | 1 1.32 97.37 One Post Office Square | 1 1.32 98.68 PO Box 43255 | 1 1.32 100.00 --------------------------+----------------------------------- Total | 76 100.00 Frequencies for address2 variable in enfrep20170222 dataset : Address2 | Freq. Percent Cum. ------------+----------------------------------- | 74 97.37 97.37 PO BOX 6101 | 2 2.63 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for city variable in enfrep20170222 dataset : City | Freq. Percent Cum. -----------------+----------------------------------- Acton | 1 1.32 1.32 Athens | 3 3.95 5.26 Austin | 9 11.84 17.11 Bedford | 10 13.16 30.26 Bells | 1 1.32 31.58 Bloomingdale | 1 1.32 32.89 Bradley Beach | 1 1.32 34.21 Calistoga | 1 1.32 35.53 Center Valley | 1 1.32 36.84 Cleveland | 2 2.63 39.47 Davie | 1 1.32 40.79 Durham | 1 1.32 42.11 Elkton | 1 1.32 43.42 Franklin Lakes | 1 1.32 44.74 Gardena | 1 1.32 46.05 Hartland | 1 1.32 47.37 Hillsboro | 1 1.32 48.68 Hudson | 9 11.84 60.53 Irvine | 1 1.32 61.84 Madison | 1 1.32 63.16 Malvern | 4 5.26 68.42 Marcy L'Etoile | 1 1.32 69.74 Montclair | 1 1.32 71.05 New Bedford | 1 1.32 72.37 New York | 2 2.63 75.00 Newark | 2 2.63 77.63 North Wales | 1 1.32 78.95 Parsippany | 1 1.32 80.26 Pittsburgh | 2 2.63 82.89 Plainsboro | 2 2.63 85.53 Plano | 1 1.32 86.84 Plymouth | 1 1.32 88.16 Redmond | 1 1.32 89.47 Tarrytown | 1 1.32 90.79 Temecula | 1 1.32 92.11 Warsaw | 3 3.95 96.05 Waukesha | 1 1.32 97.37 Westlake Village | 1 1.32 98.68 Winston Salem | 1 1.32 100.00 -----------------+----------------------------------- Total | 76 100.00 Frequencies for stateprovince variable in enfrep20170222 dataset : State/Provi | nce | Freq. Percent Cum. ------------+----------------------------------- | 1 1.32 1.32 CA | 5 6.58 7.89 DE | 2 2.63 10.53 FL | 1 1.32 11.84 IL | 1 1.32 13.16 IN | 3 3.95 17.11 MA | 2 2.63 19.74 MD | 1 1.32 21.05 MN | 1 1.32 22.37 NC | 2 2.63 25.00 NH | 9 11.84 36.84 NJ | 7 9.21 46.05 NY | 3 3.95 50.00 OH | 2 2.63 52.63 OR | 1 1.32 53.95 PA | 8 10.53 64.47 TN | 1 1.32 65.79 TX | 23 30.26 96.05 WA | 1 1.32 97.37 WI | 2 2.63 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for postalcode variable in enfrep20170222 dataset : Postal Code | Freq. Percent Cum. ------------+----------------------------------- | 1 1.32 1.32 01720 | 1 1.32 2.63 02740-7204 | 1 1.32 3.95 03051-4929 | 9 11.84 15.79 07043-0255 | 1 1.32 17.11 07054-1120 | 1 1.32 18.42 07417-1815 | 1 1.32 19.74 07720-1054 | 1 1.32 21.05 07940-1051 | 1 1.32 22.37 08536-3004 | 1 1.32 23.68 08536-3344 | 1 1.32 25.00 10065-6275 | 2 2.63 27.63 10591-5005 | 1 1.32 28.95 15238-2809 | 2 2.63 31.58 18034-8217 | 1 1.32 32.89 19355-1418 | 4 5.26 38.16 19454-1505 | 1 1.32 39.47 19702-2466 | 2 2.63 42.11 21921-5315 | 1 1.32 43.42 27127-2043 | 1 1.32 44.74 27703-8446 | 1 1.32 46.05 33317-7424 | 1 1.32 47.37 38006 | 1 1.32 48.68 44143-2131 | 2 2.63 51.32 46582-6989 | 3 3.95 55.26 53029-8347 | 1 1.32 56.58 53188-1615 | 1 1.32 57.89 55441-4575 | 1 1.32 59.21 60108-2176 | 1 1.32 60.53 75024-4100 | 1 1.32 61.84 75751-5002 | 3 3.95 65.79 76021-5950 | 10 13.16 78.95 78703-5424 | 8 10.53 89.47 78758-5445 | 1 1.32 90.79 90248-2913 | 1 1.32 92.11 91362-4001 | 1 1.32 93.42 92591-4630 | 1 1.32 94.74 92618-2346 | 1 1.32 96.05 94515-1425 | 1 1.32 97.37 97124-9432 | 1 1.32 98.68 98052-2003 | 1 1.32 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for country variable in enfrep20170222 dataset : Country | Freq. Percent Cum. --------------+----------------------------------- France | 1 1.32 1.32 United States | 75 98.68 100.00 --------------+----------------------------------- Total | 76 100.00 Frequencies for voluntarymandated variable in enfrep20170222 dataset : Voluntary/Mandated | Freq. Percent Cum. --------------------------+----------------------------------- Voluntary: Firm Initiated | 76 100.00 100.00 --------------------------+----------------------------------- Total | 76 100.00 Frequencies for initialfirmnotificationofconsign variable in enfrep20170222 dat Initial Firm Notification of Consignee | or Public | Freq. Percent Cum. ----------------------------------------+----------------------------------- E-Mail | 18 23.68 23.68 FAX | 10 13.16 36.84 Letter | 41 53.95 90.79 Other | 2 2.63 93.42 Press Release | 1 1.32 94.74 Two or more of the following: Email, .. | 4 5.26 100.00 ----------------------------------------+----------------------------------- Total | 76 100.00 Frequencies for distributionpattern variable in enfrep20170222 dataset : Distribution Pattern | Freq. Percent Cum. ----------------------------------------+----------------------------------- AL, AR, IA, IL, IN, KY, LA, MO, NC, O.. | 1 1.32 1.32 According to the firm the product was.. | 8 10.53 11.84 CA | 1 1.32 13.16 CA only | 1 1.32 14.47 Distributed throughout the United Sta.. | 2 2.63 17.11 Distribution was nationwide to medica.. | 1 1.32 18.42 Domestic: 0 Foreign: Singapore & M.. | 1 1.32 19.74 Domestic: None VA/DOD: None Foreign.. | 1 1.32 21.05 Italy | 1 1.32 22.37 MA and OH | 1 1.32 23.68 Nationwide | 4 5.26 28.95 Nationwide in US | 1 1.32 30.26 Nationwide in the US | 1 1.32 31.58 Nationwide in the United States | 1 1.32 32.89 Nationwide within US | 1 1.32 34.21 Nationwide, Bulgaria, Serbia, Cyprus,.. | 1 1.32 35.53 Nationwide. CANADA AUSTRALIA .. | 1 1.32 36.84 New Jersey and Maryland. | 1 1.32 38.16 New York; California | 2 2.63 40.79 OH, PA | 2 2.63 43.42 Products were distributed in the foll.. | 2 2.63 46.05 TX. NC, NY, FL, WI, KY, MI, CA, TN, G.. | 1 1.32 47.37 Terumo Cardiovascular has identi.. | 1 1.32 48.68 Texas | 10 13.16 61.84 U.S. | 1 1.32 63.16 U.S. Nationwide and Puerto Rico | 1 1.32 64.47 U.S. distribution to the following; M.. | 1 1.32 65.79 US Nationwide - US Nationwide in the .. | 1 1.32 67.11 US state of FL | 1 1.32 68.42 US: Germany, Italy, Puerto Rico, Spai.. | 1 1.32 69.74 USA (nationwide Distribution). | 1 1.32 71.05 United States distribution | 4 5.26 76.32 Worldwide Distribution - Costa Rica, .. | 1 1.32 77.63 Worldwide Distribution - US (nationwi.. | 7 9.21 86.84 Worldwide Distribution - US (nationwi.. | 3 3.95 90.79 Worldwide Distribution - US Nationwid.. | 1 1.32 92.11 Worldwide Distribution - US Nationwid.. | 1 1.32 93.42 Worldwide Distribution - US Nationwid.. | 1 1.32 94.74 Worldwide Distribution - USA (nationw.. | 1 1.32 96.05 Worldwide Distribution - USA (nationw.. | 1 1.32 97.37 Worldwide Distribution- US (nationwid.. | 1 1.32 98.68 Worldwide Distribution-US ( nationwid.. | 1 1.32 100.00 ----------------------------------------+----------------------------------- Total | 76 100.00 Frequencies for recallnumber variable in enfrep20170222 dataset : Recall | Number | Freq. Percent Cum. ------------+----------------------------------- B-0343-2017 | 1 1.32 1.32 B-0344-2017 | 1 1.32 2.63 B-0345-2017 | 1 1.32 3.95 B-0346-2017 | 1 1.32 5.26 B-0347-2017 | 1 1.32 6.58 B-0348-2017 | 1 1.32 7.89 B-0349-2017 | 1 1.32 9.21 B-0350-2017 | 1 1.32 10.53 B-0351-2017 | 1 1.32 11.84 B-0352-2017 | 1 1.32 13.16 B-0354-2017 | 1 1.32 14.47 B-0355-2017 | 1 1.32 15.79 B-0356-2017 | 1 1.32 17.11 D-0472-2017 | 1 1.32 18.42 D-0473-2017 | 1 1.32 19.74 D-0474-2017 | 1 1.32 21.05 D-0476-2017 | 1 1.32 22.37 D-0477-2017 | 1 1.32 23.68 D-0478-2017 | 1 1.32 25.00 D-0479-2017 | 1 1.32 26.32 F-1468-2017 | 1 1.32 27.63 F-1470-2017 | 1 1.32 28.95 F-1471-2017 | 1 1.32 30.26 F-1472-2017 | 1 1.32 31.58 F-1473-2017 | 1 1.32 32.89 F-1474-2017 | 1 1.32 34.21 F-1475-2017 | 1 1.32 35.53 F-1476-2017 | 1 1.32 36.84 F-1477-2017 | 1 1.32 38.16 F-1478-2017 | 1 1.32 39.47 F-1480-2017 | 1 1.32 40.79 F-1481-2017 | 1 1.32 42.11 F-1483-2017 | 1 1.32 43.42 F-1484-2017 | 1 1.32 44.74 F-1485-2017 | 1 1.32 46.05 F-1486-2017 | 1 1.32 47.37 F-1513-2017 | 1 1.32 48.68 Z-1103-2017 | 1 1.32 50.00 Z-1123-2017 | 1 1.32 51.32 Z-1186-2017 | 1 1.32 52.63 Z-1187-2017 | 1 1.32 53.95 Z-1188-2017 | 1 1.32 55.26 Z-1189-2017 | 1 1.32 56.58 Z-1190-2017 | 1 1.32 57.89 Z-1191-2017 | 1 1.32 59.21 Z-1192-2017 | 1 1.32 60.53 Z-1193-2017 | 1 1.32 61.84 Z-1194-2017 | 1 1.32 63.16 Z-1195-2017 | 1 1.32 64.47 Z-1196-2017 | 1 1.32 65.79 Z-1197-2017 | 1 1.32 67.11 Z-1198-2017 | 1 1.32 68.42 Z-1199-2017 | 1 1.32 69.74 Z-1200-2017 | 1 1.32 71.05 Z-1201-2017 | 1 1.32 72.37 Z-1202-2017 | 1 1.32 73.68 Z-1203-2017 | 1 1.32 75.00 Z-1204-2017 | 1 1.32 76.32 Z-1205-2017 | 1 1.32 77.63 Z-1206-2017 | 1 1.32 78.95 Z-1207-2017 | 1 1.32 80.26 Z-1208-2017 | 1 1.32 81.58 Z-1209-2017 | 1 1.32 82.89 Z-1210-2017 | 1 1.32 84.21 Z-1211-2017 | 1 1.32 85.53 Z-1212-2017 | 1 1.32 86.84 Z-1213-2017 | 1 1.32 88.16 Z-1214-2017 | 1 1.32 89.47 Z-1215-2017 | 1 1.32 90.79 Z-1216-2017 | 1 1.32 92.11 Z-1217-2017 | 1 1.32 93.42 Z-1218-2017 | 1 1.32 94.74 Z-1219-2017 | 1 1.32 96.05 Z-1220-2017 | 1 1.32 97.37 Z-1221-2017 | 1 1.32 98.68 Z-1222-2017 | 1 1.32 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for classification variable in enfrep20170222 dataset : Classificat | ion | Freq. Percent Cum. ------------+----------------------------------- Class I | 14 18.42 18.42 Class II | 46 60.53 78.95 Class III | 16 21.05 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for productdescription variable in enfrep20170222 dataset : Product Description | Freq. Percent Cum. ----------------------------------------+----------------------------------- To facilitate postoperative collecti.. | 6 7.89 7.89 To facilitate postoperative collecti.. | 1 1.32 9.21 1.5mm System, Cranio-maxillofacial Bo.. | 1 1.32 10.53 6-hole Pubic Symphysis plate (PN 70-0.. | 1 1.32 11.84 ARTISTE MV System, medical charged-pa.. | 1 1.32 13.16 Apheresis Fresh Frozen Plasma | 1 1.32 14.47 Apheresis Platelets, Leukocytes Reduced | 1 1.32 15.79 Apheresis Red Blood Cells, Leukocytes.. | 1 1.32 17.11 Arthrex¿ Shoulder Suspension Tower; C.. | 1 1.32 18.42 Atrium PVC 8 Fr Straight Thoracic Ca.. | 1 1.32 19.74 Atrium PVC 10 Fr Straight Thoracic Ca.. | 1 1.32 21.05 BD Vacutainer Buffered Sodium Citrat.. | 1 1.32 22.37 BONE MARROW ASPIRATION NEEDLE 15G x 2.. | 1 1.32 23.68 Blood and Blood Products for Reproces.. | 1 1.32 25.00 BrightView X upgraded to XCT 882454 | 1 1.32 26.32 BrightView XCT | 1 1.32 27.63 Burts British Hand Cooked Potato Chip.. | 1 1.32 28.95 CentraLink¿ Data Management System So.. | 1 1.32 30.26 Comprehensive Reverse Shoulder System.. | 1 1.32 31.58 Cryoprecipitated AHF | 1 1.32 32.89 Crystal Geyser Sparkling Mineral Wate.. | 1 1.32 34.21 Discovery MR450 The Discovery MR75.. | 1 1.32 35.53 Fresh Frozen Plasma | 1 1.32 36.84 GN200 Caiman HF generators, electrosu.. | 1 1.32 38.16 Giant Eagle Apple Pistachio Salad wit.. | 1 1.32 39.47 Giant Eagle Apple Pistachio Salad, NE.. | 1 1.32 40.79 Glipizide extended-release tablets, 2.. | 1 1.32 42.11 HARVEST NEEDLE 15GA X 2 Intended f.. | 1 1.32 43.42 Hercules 360 Universal Stabilizing Ar.. | 1 1.32 44.74 Integra Cadence Total Ankle System | 1 1.32 46.05 Joe Chips Retro Potato Chips Sour Cre.. | 1 1.32 47.37 LIFEPAK 15 Monitor, Automated Externa.. | 1 1.32 48.68 LIMA Modular Revision Hip Stem Model .. | 1 1.32 50.00 Lisinopril tablets, 5 mg, 1000-count .. | 1 1.32 51.32 MegaJex Herbal Supplement, Maximum Fo.. | 1 1.32 52.63 Mimvey Lo (estradiol and norethindron.. | 1 1.32 53.95 NOW¿ Multi-Food 1 Tablets, One Tablet.. | 1 1.32 55.26 ONCOR Avant-garde, medical charged-pa.. | 1 1.32 56.58 ONCOR Impression, ONCOR Impression pl.. | 1 1.32 57.89 Offset Reamer Handle, T5766 Produc.. | 1 1.32 59.21 PICTSWEET(R) FARMS, Southern Classic.. | 1 1.32 60.53 PIER FISH CO. 68 CONWAY ST NEW BEDFOR.. | 1 1.32 61.84 PRIMUS Medical charged-particle radia.. | 1 1.32 63.16 Pizza Hut Creamy Alfredo sauce, case .. | 1 1.32 64.47 Platelets | 1 1.32 65.79 Platelets, Leukocytes Reduced | 1 1.32 67.11 Red Blood Cells, Leukocytes Reduced | 1 1.32 68.42 Red Blood Cells, Leukocytes Reduced, .. | 2 2.63 71.05 SLIMFIT X capsules, packaged in a 60-.. | 1 1.32 72.37 STERRAD NX Sterilization System, Prod.. | 1 1.32 73.68 Source Plasma | 1 1.32 75.00 StarClose SE Vascular Closure System,.. | 1 1.32 76.32 Stryker Restoris RIO Reamer Handle, O.. | 1 1.32 77.63 T-LOK BONE MARROW BIOPSY NEEDLE 8G x .. | 1 1.32 78.95 Taclonex (calcipotriene and betametha.. | 1 1.32 80.26 The Enzyme 2 Calibrator is an in vitr.. | 1 1.32 81.58 The Enzyme II Calibrator is an in vit.. | 1 1.32 82.89 The Schiller PB 1000, also known as: .. | 1 1.32 84.21 VIDAS 3 software v. 1.1.4 | 1 1.32 85.53 Vanguard Total Knee, PUNCH THRU TRL P.. | 1 1.32 86.84 Venlafaxine Hydrochloride extended re.. | 1 1.32 88.16 Washed Red Blood Cells, Leukocytes Re.. | 1 1.32 89.47 Whole Foods Market, SMALLTART FRESH B.. | 1 1.32 90.79 Whole Foods Market, TART CHOCOLATE GA.. | 1 1.32 92.11 Whole Foods Market, TART FRENCH APPLE.. | 1 1.32 93.42 Whole Foods Market, TART FRESH FRUIT .. | 1 1.32 94.74 Whole Foods Market, TART FRUIT 4IN | 1 1.32 96.05 Whole Foods Market, TART KEY LIME 4IN.. | 1 1.32 97.37 Whole Foods Market, TART LEMON SMALL | 1 1.32 98.68 Whole Foods Market, TART PEANUT BUTTE.. | 1 1.32 100.00 ----------------------------------------+----------------------------------- Total | 76 100.00 Frequencies for productquantity variable in enfrep20170222 dataset : Product Quantity | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 3 3.95 3.95 1 case (6 units) | 2 2.63 6.58 1 unit | 6 7.89 14.47 1,441 | 1 1.32 15.79 1,488,800 tubes | 1 1.32 17.11 10,233.00 | 1 1.32 18.42 10,965.64 | 1 1.32 19.74 100 bottles | 1 1.32 21.05 1008 x 28 pack casaes or 24,192 bottles | 1 1.32 22.37 11 | 1 1.32 23.68 112 devices | 1 1.32 25.00 1161 units | 1 1.32 26.32 125 units | 1 1.32 27.63 12896 bottles | 1 1.32 28.95 13 devices | 1 1.32 30.26 13,147 units | 1 1.32 31.58 1394 cases (10/case) | 1 1.32 32.89 15 boxes | 1 1.32 34.21 15 units | 1 1.32 35.53 150 bottles | 1 1.32 36.84 17,473 cartons | 1 1.32 38.16 170,008 units total (83,029 units in .. | 1 1.32 39.47 18 units | 1 1.32 40.79 189,610 units | 1 1.32 42.11 194 systems | 4 5.26 47.37 2 units | 1 1.32 48.68 21 units | 1 1.32 50.00 212 units | 1 1.32 51.32 24,940.00 | 1 1.32 52.63 245 cases (1470 units) | 1 1.32 53.95 26 | 1 1.32 55.26 26 units | 1 1.32 56.58 268 | 1 1.32 57.89 27 cases (162 units) | 1 1.32 59.21 27,210 units; (4535 cases of 6 units/.. | 1 1.32 60.53 2933 cases (17598 units) | 1 1.32 61.84 3 cases (18 units) | 1 1.32 63.16 3,893 units | 1 1.32 64.47 338 units total (US =139 units; Inter.. | 1 1.32 65.79 34 cases | 1 1.32 67.11 341 sites potentially have the affect.. | 1 1.32 68.42 35 generators | 1 1.32 69.74 425 | 1 1.32 71.05 439 | 1 1.32 72.37 45 units | 1 1.32 73.68 458 | 1 1.32 75.00 47,040 bottles | 1 1.32 76.32 4822 | 1 1.32 77.63 497 boxes | 1 1.32 78.95 499320 units | 1 1.32 80.26 5 units | 1 1.32 81.58 595 units | 1 1.32 82.89 60 | 1 1.32 84.21 653 cases | 1 1.32 85.53 66 units | 1 1.32 86.84 660 cases (10/case) | 1 1.32 88.16 681 cases (4086 units) | 1 1.32 89.47 7,694 units total (5,935 units in US) | 1 1.32 90.79 70,130 bags | 1 1.32 92.11 772 boxes | 1 1.32 93.42 7830 cases | 1 1.32 94.74 9,938 bottles (90 tablets per bottle) | 1 1.32 96.05 944 units | 1 1.32 97.37 97 | 1 1.32 98.68 The total number of distributed devic.. | 1 1.32 100.00 ----------------------------------------+----------------------------------- Total | 76 100.00 Frequencies for reasonforrecall variable in enfrep20170222 dataset : Reason for Recall | Freq. Percent Cum. ----------------------------------------+----------------------------------- Blood products, collected from ineli.. | 10 13.16 13.16 A portion of this lot of blood collec.. | 1 1.32 14.47 Abbott Vascular is recalling the Star.. | 1 1.32 15.79 According to the firm, packaged crust.. | 8 10.53 26.32 Advanced Sterilization Products (ASP).. | 1 1.32 27.63 Blood products, for which donor eligi.. | 2 2.63 30.26 Chest drains manual vent valve locate.. | 7 9.21 39.47 Complaints of positive shift of patie.. | 1 1.32 40.79 Complaints of positive shift of patie.. | 1 1.32 42.11 Crystal Geyser became aware of a pote.. | 1 1.32 43.42 During development of the VIDAS 3 sof.. | 1 1.32 44.74 During use, there is a potential scen.. | 1 1.32 46.05 Elevated histamine levels. | 1 1.32 47.37 Failed Dissolution Specifications. Ab.. | 1 1.32 48.68 Failed Impurities/Degradation Specifi.. | 1 1.32 50.00 Failed Tablet/Capsule Specifications:.. | 1 1.32 51.32 Failed tablet/capsule specification: .. | 1 1.32 52.63 Failure of the Offset Cup Reamer Hand.. | 1 1.32 53.95 Foreign object in alfredo sauce. Like.. | 1 1.32 55.26 Generators may have a faulty componen.. | 1 1.32 56.58 Higher than anticipated rate of fract.. | 1 1.32 57.89 Joe Chips Sour Cream & Toasted Onion .. | 1 1.32 59.21 Labeling icon depicts a catheter hav.. | 2 2.63 61.84 Labeling: Incorrect or missing packag.. | 1 1.32 63.16 Lima Proximal Bodies were inadvertent.. | 1 1.32 64.47 Marketed without an Approved NDA/ANDA.. | 1 1.32 65.79 Marketed without an approved NDA/ANDA.. | 1 1.32 67.11 Non-invasive blood pressure pumps (NI.. | 1 1.32 68.42 On June 14, 2016, Greatbatch discover.. | 1 1.32 69.74 Plasma products, for which a failure .. | 1 1.32 71.05 Posterior tibial fractures have been .. | 1 1.32 72.37 Potential safety issue with the patie.. | 1 1.32 73.68 Product is labeled as gluten free; ho.. | 1 1.32 75.00 Product may contain glass fragments | 1 1.32 76.32 Product's supplement fact panel incor.. | 1 1.32 77.63 Siemens became aware of Incorrect val.. | 4 5.26 82.89 Terumo Cardiovascular Systems (Terumo.. | 1 1.32 84.21 The 6-hole Pubic Symphysis plate (PN .. | 1 1.32 85.53 The firm has become aware of a potent.. | 1 1.32 86.84 The identification of the devices was.. | 1 1.32 88.16 The intended use listed in the Englis.. | 2 2.63 90.79 The recalling firm received a complai.. | 3 3.95 94.74 The sliced red apples were recalled d.. | 2 2.63 97.37 There is a remote possibility CentraL.. | 1 1.32 98.68 Zimmer Biomet is conducting a medical.. | 1 1.32 100.00 ----------------------------------------+----------------------------------- Total | 76 100.00 Frequencies for centerclassificationdate variable in enfrep20170222 dataset : Center | Classificat | ion Date | Freq. Percent Cum. ------------+----------------------------------- 02/10/2017 | 21 27.63 27.63 02/13/2017 | 15 19.74 47.37 02/14/2017 | 10 13.16 60.53 02/15/2017 | 19 25.00 85.53 02/16/2017 | 11 14.47 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for terminationdate variable in enfrep20170222 dataset : Termination | Date | Freq. Percent Cum. ------------+----------------------------------- | 60 78.95 78.95 02/10/2017 | 10 13.16 92.11 02/14/2017 | 3 3.95 96.05 02/15/2017 | 2 2.63 98.68 02/16/2017 | 1 1.32 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for codeinfo variable in enfrep20170222 dataset : Code Info | Freq. Percent Cum. ----------------------------------------+----------------------------------- Mfg. Lot or Serial # System ID 0.. | 1 1.32 1.32 1) Lot 02082018; and 2) Lot 02072018.. | 1 1.32 2.63 1005528A, 1006882A, 1107305A, 110179.. | 1 1.32 3.95 22024600000 TART PEANUT BUTTER CHOCO.. | 1 1.32 5.26 23143000000 TART LEMON SMALL | 1 1.32 6.58 2481193, 2468380, 2599785, 2463309, .. | 1 1.32 7.89 24978300000 TART CHOCOLATE GANACHE S.. | 1 1.32 9.21 24982800000 TART FRENCH APPLE SMALL | 1 1.32 10.53 24983100000 TART FRESH BERRY SMALL .. | 1 1.32 11.84 24984100000 TART FRESH FRUIT AMERO S.. | 1 1.32 13.16 24985200000 TART FRUIT 4IN | 1 1.32 14.47 24989600000 TART KEY LIME 4IN 23144.. | 1 1.32 15.79 3410340320; 3410340831; 3410341674; .. | 1 1.32 17.11 6000013 6000025 6000029 6000036 .. | 1 1.32 18.42 95-6104- Item No. 530430- Lot 1.5.. | 1 1.32 19.74 All Lot Numbers With Expiration Date.. | 2 2.63 22.37 All Lots exp. date 12/2019 | 1 1.32 23.68 All lots and all expiration dates. | 1 1.32 25.00 All lots recalled, Catalog No. 20708.. | 1 1.32 26.32 Codes 7C032 0400 to 7C032 0600 | 1 1.32 27.63 Lot # 33809881A, Exp 05/17; 33811151.. | 1 1.32 28.95 Lot # T04483, T04484, Exp 2/18; T060.. | 1 1.32 30.26 Lot #: (a): EK9025, Exp. 2/28/2017.. | 1 1.32 31.58 Lot #: 0217, 0317, 040617, 0517, 160.. | 1 1.32 32.89 Lot #: 3134201, 3134202, Exp. 06/30.. | 1 1.32 34.21 Lot #: VI3716010-A, Exp. 04/2018 | 1 1.32 35.53 Lot 6090572 | 1 1.32 36.84 Lot Number: 4MD048, 5DD026, 5ED071,.. | 1 1.32 38.16 Lot Number: 242896, 243292 | 1 1.32 39.47 Lot Number: 242897 | 1 1.32 40.79 Lot Number: 242909, 242910, 242912, .. | 1 1.32 42.11 Lot Number: 242919, 242920 | 1 1.32 43.42 Lot Number: 243295 | 1 1.32 44.74 Lot Number: 243312 | 1 1.32 46.05 Lot Number: 243842 | 1 1.32 47.37 Lot number: 383813 | 1 1.32 48.68 Lot numbers 041870 041880 041890 .. | 1 1.32 50.00 Lot# 16185 | 1 1.32 51.32 Lots 1944987 and 1989171 | 1 1.32 52.63 Model Number, Item Description, and .. | 1 1.32 53.95 Model Number: 1940035 and 4504200 S.. | 1 1.32 55.26 Model Number: 5857920 Serial Number.. | 1 1.32 56.58 Model Number: 5863472, 5857920 and 5.. | 1 1.32 57.89 Model Number: 8139789 Serial Number.. | 1 1.32 59.21 Part No. 14679-01 50908K1 50916K1 .. | 1 1.32 60.53 Patient Data Module (PDM) V2 model: .. | 1 1.32 61.84 Product Lot: 4MD047, 5CD052, 5FD017.. | 1 1.32 63.16 Product codes: 10485061, 10484212, .. | 1 1.32 64.47 REF: #412590, Lot: Software version .. | 1 1.32 65.79 SELL BY: 12/1/14; 12/2/14; 12/3/14; .. | 2 2.63 68.42 SERIAL NUMBERS: 42738872, 4455410.. | 1 1.32 69.74 Serial # 1229 1897 1898 1900 1909 1.. | 1 1.32 71.05 Serial No 33100270 33110267 10033.. | 1 1.32 72.37 Serial Number Range 70194 through 70.. | 1 1.32 73.68 Serial Numbers: 501798, 501799, 5018.. | 1 1.32 75.00 Two systems were converted into the .. | 1 1.32 76.32 Vanguard Total Knee, PUNCH THRU TRL .. | 1 1.32 77.63 W0352162214237; W035216224390; W0352.. | 1 1.32 78.95 W035216221954 (double collection); W.. | 1 1.32 80.26 W035216221960; W035216221954; W03521.. | 1 1.32 81.58 W035216221965 (double collection); W.. | 1 1.32 82.89 W035216221972; | 1 1.32 84.21 W035216224391; | 1 1.32 85.53 W035216242690; W035216242690; | 1 1.32 86.84 W035216242703; W035216242703; W03521.. | 1 1.32 88.16 W035216269137; | 1 1.32 89.47 W035216282408 | 1 1.32 90.79 W047016206493 | 2 2.63 93.42 date of Nov 3, 2018 and a production.. | 1 1.32 94.74 expiration 2 oz size 27-MARCH-201.. | 1 1.32 96.05 lots: 11156986, 11158618, 11158620 | 1 1.32 97.37 lots: 11157523, 11158179, 11158180, .. | 1 1.32 98.68 lots: 11158857 | 1 1.32 100.00 ----------------------------------------+----------------------------------- Total | 76 100.00 Frequencies for morecodeinfo1 variable in enfrep20170222 dataset : More Code Info 1 | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 75 98.68 98.68 1 33101142 33111364 33111143 1003.. | 1 1.32 100.00 ----------------------------------------+----------------------------------- Total | 76 100.00 Frequencies for recallinitiationdate variable in enfrep20170222 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 20aug2014 | 1 1.32 1.32 10dec2014 | 2 2.63 3.95 31may2015 | 1 1.32 5.26 05may2016 | 2 2.63 7.89 29sep2016 | 1 1.32 9.21 19oct2016 | 1 1.32 10.53 29nov2016 | 1 1.32 11.84 30nov2016 | 1 1.32 13.16 09dec2016 | 1 1.32 14.47 15dec2016 | 1 1.32 15.79 16dec2016 | 2 2.63 18.42 20dec2016 | 2 2.63 21.05 22dec2016 | 1 1.32 22.37 23dec2016 | 9 11.84 34.21 24dec2016 | 1 1.32 35.53 28dec2016 | 1 1.32 36.84 02jan2017 | 8 10.53 47.37 03jan2017 | 1 1.32 48.68 09jan2017 | 2 2.63 51.32 10jan2017 | 2 2.63 53.95 11jan2017 | 1 1.32 55.26 12jan2017 | 1 1.32 56.58 13jan2017 | 2 2.63 59.21 16jan2017 | 2 2.63 61.84 18jan2017 | 3 3.95 65.79 19jan2017 | 1 1.32 67.11 20jan2017 | 6 7.89 75.00 24jan2017 | 10 13.16 88.16 25jan2017 | 4 5.26 93.42 30jan2017 | 2 2.63 96.05 02feb2017 | 1 1.32 97.37 08feb2017 | 1 1.32 98.68 10feb2017 | 1 1.32 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for recallinitiationdatestr variable in enfrep20170222 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 01/02/2017 | 8 10.53 10.53 01/03/2017 | 1 1.32 11.84 01/09/2017 | 2 2.63 14.47 01/10/2017 | 2 2.63 17.11 01/11/2017 | 1 1.32 18.42 01/12/2017 | 1 1.32 19.74 01/13/2017 | 2 2.63 22.37 01/16/2017 | 2 2.63 25.00 01/18/2017 | 3 3.95 28.95 01/19/2017 | 1 1.32 30.26 01/20/2017 | 6 7.89 38.16 01/24/2017 | 10 13.16 51.32 01/25/2017 | 4 5.26 56.58 01/30/2017 | 2 2.63 59.21 02/02/2017 | 1 1.32 60.53 02/08/2017 | 1 1.32 61.84 02/10/2017 | 1 1.32 63.16 05/05/2016 | 2 2.63 65.79 05/31/2015 | 1 1.32 67.11 08/20/2014 | 1 1.32 68.42 09/29/2016 | 1 1.32 69.74 10/19/2016 | 1 1.32 71.05 11/29/2016 | 1 1.32 72.37 11/30/2016 | 1 1.32 73.68 12/09/2016 | 1 1.32 75.00 12/10/2014 | 2 2.63 77.63 12/15/2016 | 1 1.32 78.95 12/16/2016 | 2 2.63 81.58 12/20/2016 | 2 2.63 84.21 12/22/2016 | 1 1.32 85.53 12/23/2016 | 9 11.84 97.37 12/24/2016 | 1 1.32 98.68 12/28/2016 | 1 1.32 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for reportdate variable in enfrep20170222 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 22feb2017 | 76 100.00 100.00 ------------+----------------------------------- Total | 76 100.00 Frequencies for reportdatestr variable in enfrep20170222 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 02/22/2017 | 76 100.00 100.00 ------------+----------------------------------- Total | 76 100.00 by Jean Roth , jroth@nber.org , 23 Feb 2017