Pouch, Colostomy
Gastroenterology, Urology · 21 CFR 876.5900
Recent MDR events
2,020 adverse event reports on file
- NATURA+Apr 24, 2026InjuryUnomedical S.r.o.3005778470-2026-00587
- ESTEEM+Feb 17, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-00368
- ESTEEM+Feb 17, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-00367
- ESTEEM+Feb 17, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-00365
- ESTEEM+Feb 17, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-00366
- ESTEEM+Feb 17, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-00356
- ESTEEM+Jan 15, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-00057
- ESTEEM+Jan 15, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-00312
- ESTEEM+Jan 15, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-00313
- ESTEEM+Jan 15, 2026MalfunctionConvatec Dominican Republic Inc9618003-2026-00314
Event type breakdown
Recalls
5 recall events for this product code
- ConvaTec, IncOpen, ClassifiedOct 24, 2022
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy pro
impaired functionality of the release liner
Z-0127-2023 · View FDA record ↗ - ConvaTec, IncOpen, ClassifiedOct 24, 2022
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975.
impaired functionality of the release liner
Z-0128-2023 · View FDA record ↗ - ConvaTec, IncOpen, ClassifiedOct 24, 2022
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy proce
impaired functionality of the release liner
Z-0129-2023 · View FDA record ↗ - ConvaTec, IncOpen, ClassifiedOct 24, 2022
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy proce
impaired functionality of the release liner
Z-0130-2023 · View FDA record ↗ - Convatec Inc.TerminatedOct 18, 2010
ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier;
Mislabeled: the market units were incorrectly labeled as # 125339 ActiveLife Drainable Pouch 25 mm; the product inside was actually ActiveLife Pouch Small Tan 32 mm, ICC # 125333.
Z-0073-2011 · View FDA record ↗
Registered firms
49 firms currently registered for this product code
Anji Spenq Industrial Co., Ltd.
Huzhou Zhejiang, CN
Dongguan Kangda Medical Technology Co., Ltd
Dongguan Guangdong, CN
Casex, Ltda
Curitiba Parana, BR
Rece International Corp.
Miami, FL, US
Dongguan Bao Kang Dian Zi Ke Ji Limited
Dongguan City Guangdong, CN
Dongguan City Risen Medical Products Co., Ltd
Dongguan Guangdong, CN
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
Cankaya Ankara, TR
Versipel, Llc
Dunmore, PA, US
Gentell
Bristol, PA, US
Revel Next Inc.
N Billerica, MA, US
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Ningbo Greetmed Medical Instruments Co., Ltd.
Ningbo Zhejiang, CN
K-med Co., Ltd.
Yangzhou Jiangsu, CN
Convatec Limited
Deeside Flintshire, GB
Convatec Limited, Gdc Building
Deeside Flintshire, GB
Hangzhou Rollmed Co.,ltd.
Hangzhou Zhejiang, CN
Blunding S.a.
MACUL SANTIAGO Region Metropolitana, CL
Shanghai Joy Crown Industry Co., Ltd
Pu Dong New Area Shanghai, CN
For Life Gmbh
BERLIN, DE
Convatec Dominican Republic, Inc.
Haina San Cristobal, DO
Pharmaplast S.a.e.
ALEXANDRIA Al Iskandariyah, EG
Wenzhou Celecare Medical Lnstruments Co.,ltd.
wenzhou Zhejiang, CN
Amparo Medical Technologies, Inc.
Anaheim, CA, US
The Hibbert Group - Wdc Delaware
New Castle, DE, US
510(k) clearances
6 clearances for this product code
- Convatec, Inc.Aug 19, 2011
K111365 · VITALA CONTINENCE CONTROL DEVICE
- Convatec, Inc.Dec 1, 2010
K102536 · VITALA CONTINENCE CONTROL DEVICE
- ConvatecApr 2, 2010
K083785 · VITALA CONTINENCE CONTROL DEVICE
- Boston Pacific Medical, Inc.Jun 10, 1992
K922401 · 4 SURE TM COLOSTOMY POUCH
- Marlen Mfg. & Development Co.Feb 19, 1988
K880327 · MARLEN ULTRA ILEOSTOMY POUCH-5000
- Coloplast A/SOct 16, 1986
K863830 · CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM