Appliance, Colostomy, Disposable
Gastroenterology, Urology · 21 CFR 876.5900
Recent MDR events
49 adverse event reports on file
- ACCESSORIESNov 10, 2020InjuryConvatec Inc1049092-2020-00179
- ESTEEM SYNERGYJun 8, 2018MalfunctionConvatec Dominican Republic Inc9618003-2018-00386
- ESTEEM SYNERGYJun 8, 2018MalfunctionConvatec Dominican Republic Inc9618003-2018-00387
- ESTEEM SYNERGYJun 8, 2018MalfunctionConvatec Dominican Republic Inc9618003-2018-00388
- ESTEEM SYNERGYJun 8, 2018MalfunctionConvatec Dominican Republic Inc9618003-2018-00305
- Unnamed deviceSep 5, 2017Injury1049092-2017-00047
- DUOLOCK TAIL CLSR CURVED TANJun 22, 2016MalfunctionConvatec Dom. Republic, Inc9618003-2016-00028
- DUOLOCK TAIL CLSR CURVED TANMar 25, 2016MalfunctionConvatec Limited1000317571-2016-00032
- DUOLOCK TAIL CLSR CURVED TANMar 25, 2016MalfunctionConvatec Limited1000317571-2016-00031
- SUR-FIT NATURA 2 PC - DISPOSABLE CONVEX INSERTJun 4, 2014InjuryConvatec Inc1049092-2014-00168
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
31 firms currently registered for this product code
Hollister Incorporated
LIBERTYVILLE, IL, US
Convatec, Inc.
Greensboro, NC, US
Versipel, Llc
Dunmore, PA, US
Amsino Medical (kunshan) Co., Ltd.
KUNSHAN CITY Jiangsu, CN
The Hibbert Group - Wdc Delaware
New Castle, DE, US
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Gentell
Bristol, PA, US
Fistula Solution Corporation
Scandia, MN, US
Pharmaplast S.a.e.
ALEXANDRIA Al Iskandariyah, EG
Atlas Medical Products Llc
Hialeah, FL, US
Hollister, Inc.
Mount Juliet, TN, US
Safe N Simple Llc
Clarkston, MI, US
Stymco Medical Llc
Tampa, FL, US
Salts Healthcare Limited
ASTON BIRMINGHAM, GB
O&m Halyard, Inc.
Alpharetta, GA, US
Convatec Limited, Gdc Building
Deeside Flintshire, GB
Marlen Mfg. & Development Co.
BEDFORD, OH, US
Medas, Inc.
Miami, FL, US
Colo-majic Enterprises Ltd
Maple Ridge British Columbia, CA
Convatec Dominican Republic, Inc.
Haina San Cristobal, DO
Casex, Ltda
Curitiba Parana, BR
K-med Co., Ltd.
Yangzhou Jiangsu, CN
Biotronix Healthcare Industries Inc.
Orlando, FL, US
Zhejiang Mediunion Healthcare Group Co.,ltd
Ningbo Zhejiang, CN
Hangzhou Rollmed Co.,ltd.
Hangzhou Zhejiang, CN
510(k) clearances
1 clearances for this product code