DUODERM 187661Recalls & reported problems
Convatec, Purchasing Department · DUODERM CGF DRS 15X15CM (1x5PK) NAI · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00768455102723), received between Mar 17, 2022 and May 20, 2022 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (8 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Delivered as Unsterile Product8
- Packaging Problem8
- Unsealed Device Packaging8
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT THERE WAS ONE UNIT WHICH HAD AN INCORRECT SEAL WHICH WAS CLOSE TO OPENING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14460403 ↗MalfunctionApr 25, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT THERE WERE SIX UNITS WHICH HAD AN INCORRECT SEALING AND THE PACKAGING WERE ALMOST OPENED. THE PRODUCT WAS NOT USED BY CUSTOMER. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14191755 ↗MalfunctionApr 25, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT THERE WERE SIX UNITS WHICH HAD AN INCORRECT SEALING AND THE PACKAGING WERE ALMOST OPENED. THE PRODUCT WAS NOT USED BY CUSTOMER. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14191754 ↗MalfunctionApr 25, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT THERE WERE SIX UNITS WHICH HAD AN INCORRECT SEALING AND THE PACKAGING WERE ALMOST OPENED. THE PRODUCT WAS NOT USED BY CUSTOMER. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14191753 ↗MalfunctionApr 25, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT THERE WERE SIX UNITS WHICH HAD AN INCORRECT SEALING AND THE PACKAGING WERE ALMOST OPENED. THE PRODUCT WAS NOT USED BY CUSTOMER. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14191751 ↗MalfunctionApr 25, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT THERE WERE SIX UNITS WHICH HAD AN INCORRECT SEALING AND THE PACKAGING WERE ALMOST OPENED. THE PRODUCT WAS NOT USED BY CUSTOMER. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14191750 ↗MalfunctionApr 25, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT THERE WERE SIX UNITS WHICH HAD AN INCORRECT SEALING AND THE PACKAGING WERE ALMOST OPENED. THE PRODUCT WAS NOT USED BY CUSTOMER. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14191745 ↗MalfunctionMar 17, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE DRESSING IS TRAPPED IN HERMETIC SEAL. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13800696 ↗
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- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.