Bag, Drainage, With Adhesive, Ostomy
FDA adverse event reports and recall history for bag, drainage, with adhesive, ostomy (product code FON), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 137
- Deaths
- 1
- Injuries
- 20
- Malfunctions
- 115
Reports per year
Source: FDA adverse event reports by year received, 2006–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-03-19Open, ClassifiedProcess control
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.
- 2026-03-19Open, ClassifiedProcess control
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Drainable large pouch may leak due to manufacturing issue.
- 2026-03-19Open, ClassifiedProcess control
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Drainable large pouch may leak due to manufacturing issue.
- 2024-09-30Open, ClassifiedLabeling Change Control
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
- 2024-03-21Open, ClassifiedUnder Investigation by firm
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
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