DUODERM 187932Recalls & reported problems
Convatec, Purchasing Department · DUODERM XTHIN DRS OVAL (1x20PK) NAI · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455102815), received between Aug 21, 2025 and Aug 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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
- Difficult to Remove1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2025Difficult to Remove; Difficult to Remove
THE END USER REPORTED THAT THERE WAS DIFFICULTLY REMOVING THE COMPANY¿S KNOWN DRESSING. THE MEDICAL ASSISTANT AT THE DERMATOLOGIST'S OFFICE HAD GIVEN END USER A SAMPLE OF THIS PRODUCT TO APPLY TO CYSTIC ACNE ON HER FACE. THE END USER HAD ADVISED THAT SHE ONLY WANTED TO WEAR THE PRODUCT AT NIGHT. THE MEDICAL ASSISTANT HAD ADVISED SHE COULD REMOVE IT AFTER EIGHT HOURS AND DID NOT PROVIDE ANY OTHER INSTRUCTION. THE END USER HAD TRIED TO REMOVE THE PRODUCT, AND SHE EMPHASIZED THAT THE DRESSING WAS EXTREMELY PAINFUL AND DIFFICULT TO REMOVE FROM HER FACE BECAUSE THE DRESSING WAS TOO ADHERED. SHE WAS UNABLE TO REACH ANYONE AT THE DOCTOR OF MEDICINE (MD) OFFICE. THE END USER HAD TRIED TO REMOVE THE DRESSING AFTER A HOT SHOWER AND SOAKING THE DRESSING WITH A WASHCLOTH. SHE USED SMALL PRECISION SCISSORS TO CUT AWAY THE DRESSING WHILE SOAKING IT MORE WITH A WASHCLOTH. THE END USER STATED THAT SHE HAD DECIDED THAT THE PRODUCT WAS NOT FOR HER BECAUSE SHE ONLY WANTED TO WEAR IT FOR A CERTAIN TIME FRAME, AND SHE HAD PURCHASED COMPANY¿S KNOWN GEL AND NON-STICK BANDAGES. THE PRODUCT WAS USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 22858480 ↗
Other Dressing, Wound, Occlusive devices
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- DUODERM 187961Convatec, Purchasing Department · Dressing, Wound, Occlusive153 reports
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- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
- ALLEVYN LIFE SACRUM (LARGE) PACK OF 10 66801307Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.