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EZQClass 1

Pouch, Colostomy

FDA adverse event reports and recall history for pouch, colostomy (product code EZQ), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
2,020
Deaths
1
Injuries
509
Malfunctions
1,505

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2022-10-24Open, ClassifiedUnder Investigation by firm

    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 procedure.

    impaired functionality of the release liner

  • 2022-10-24Open, ClassifiedUnder Investigation by firm

    ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.

    impaired functionality of the release liner

  • 2022-10-24Open, ClassifiedUnder Investigation by firm

    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 procedure.

    impaired functionality of the release liner

  • 2022-10-24Open, ClassifiedUnder Investigation by firm

    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 procedure.

    impaired functionality of the release liner

  • 2010-10-18TerminatedLabeling mix-ups

    ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch

    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.

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