DUODERM 187644Recalls & reported problems
Convatec, Purchasing Department · DUODERM CGF DRS 20x30CM (1x5PK) NAI · Class 1
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00768455106707), received between May 4, 2021 and Mar 2, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (11 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.
Reports received per month
Most reported problems
Device problems
- Packaging Problem11
- Delivered as Unsterile Product9
- Tear, Rip or Hole in Device Packaging8
- Unsealed Device Packaging5
- Device Damaged Prior to Use4
- Contamination /Decontamination Problem2
- Device Contaminated During Manufacture or Shipping2
Patient problems
- No Clinical Signs, Symptoms or Conditions15
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
THE DISTRIBUTOR NOTIFIED THAT OUTER BOX DENTED AND DAMAGED. HOWEVER, AS PER PHOTOGRAPHS RECEIVED, PRIMARY PACK APPEARED DAMAGED AND TORN. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24481213 ↗MalfunctionMar 2, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
THE DISTRIBUTOR NOTIFIED THAT OUTER BOX DENTED AND DAMAGED. HOWEVER, AS PER PHOTOGRAPHS RECEIVED, PRIMARY PACK APPEARED DAMAGED AND TORN. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24481017 ↗MalfunctionMar 2, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
THE DISTRIBUTOR NOTIFIED THAT OUTER BOX DENTED AND DAMAGED. HOWEVER, AS PER PHOTOGRAPHS RECEIVED, PRIMARY PACK APPEARED DAMAGED AND TORN. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24480997 ↗MalfunctionMar 2, 2026Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
THE DISTRIBUTOR NOTIFIED THAT OUTER BOX DENTED AND DAMAGED. HOWEVER, AS PER PHOTOGRAPHS RECEIVED, PRIMARY PACK APPEARED DAMAGED AND TORN. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24480781 ↗MalfunctionMay 29, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17016203 ↗MalfunctionSep 26, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15484567 ↗MalfunctionSep 26, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15484563 ↗MalfunctionSep 26, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT THE PRIMARY PACKAGING WAS CRUSHED. THE CUSTOMER DID NOT WISH TO PROVIDE FURTHER INFORMATION. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15484555 ↗MalfunctionSep 26, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT THE PRIMARY PACKAGING WAS CRUSHED. THE CUSTOMER DID NOT WISH TO PROVIDE FURTHER INFORMATION. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15484554 ↗MalfunctionSep 26, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT THE PRIMARY PACKAGING WAS CRUSHED. THE CUSTOMER DID NOT WISH TO PROVIDE FURTHER INFORMATION. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15484553 ↗MalfunctionApr 12, 2022Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem
IT WAS REPORTED THAT THE PACKAGE WAS TORN. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14081966 ↗MalfunctionApr 12, 2022Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem
IT WAS REPORTED THAT THE PACKAGE WAS TORN. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14081965 ↗MalfunctionApr 12, 2022Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem
IT WAS REPORTED THAT THE PACKAGE WAS TORN. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14081964 ↗MalfunctionMay 6, 2021Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem
IT WAS REPORTED THAT THE PACKAGE WAS DIRTY. THE PRODUCT WAS NOT USED ON PATIENT. PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11782199 ↗MalfunctionMay 4, 2021Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem
IT WAS REPORTED THAT THE PACKAGE WAS DIRTY. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11767970 ↗
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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.