DUODERM PASTE AND GELS 187987Recalls & reported problems
Convatec, Purchasing Department · DUODERM H/ACTIVE GEL (3TBEX30G) STER US · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Convatec DuoDERM wound gel is a drug-free hydrogel dressing for wounds. The 24 reports mostly describe tubes or packaging arriving unsterile, punctured, leaking, or with broken seals; the product was often not used. There were no deaths or injuries, and no recalls name this device. Reports fell from 7 to 2 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00768455172979), received between Jan 17, 2022 and Aug 26, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (23 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product23
- Device Damaged Prior to Use14
- Contamination /Decontamination Problem11
- Tear, Rip or Hole in Device Packaging11
- Packaging Problem7
- Gel Leak5
- Unsealed Device Packaging5
- Device Contaminated During Manufacture or Shipping4
Patient problems
- No Clinical Signs, Symptoms or Conditions24
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
The distributor reported the presence of puncture hole in one of the tubes. The product was not used. No photographs depicting the issue were received from the complainant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50446905 ↗MalfunctionFeb 13, 2026Gel Leak; Delivered as Unsterile Product
IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE HAD BEEN LEAKAGE IN THE GEL TUBE DESPITE THE PRODUCT BEING SEALED. THE PRODUCT WAS NOT USED, AND NO PHOTOGRAPH WAS AVAILABLE AT THE TIME OF THE REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24334287 ↗MalfunctionSep 2, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22931822 ↗MalfunctionAug 28, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS A BROKEN SEAL ON ONE UNIT OF COMPANY'S KNOWN GEL TUBE. THE BOX WAS INTACT. THE PRODUCT WAS NOT USED BY PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910872 ↗MalfunctionAug 14, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
IT WAS REPORTED BY THE DISTRIBUTOR AND END USER THAT THERE WAS LEAKAGE SINCE THE SEAL WAS OPENED. THE PRODUCT WAS USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22802609 ↗MalfunctionAug 1, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22684918 ↗MalfunctionAug 1, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22684917 ↗MalfunctionJan 28, 2025Gel Leak; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Gel Leak; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21256657 ↗MalfunctionDec 30, 2024Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21033487 ↗MalfunctionOct 29, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20555578 ↗MalfunctionAug 23, 2024Gel Leak; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Gel Leak; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20050305 ↗MalfunctionAug 22, 2024Gel Leak; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Gel Leak; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20040080 ↗MalfunctionAug 22, 2024Gel Leak; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Gel Leak; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE CUSTOMER NOTICED THREE TUBES WERE DAMAGED AND TINY HOLE APPEARED ON THE SURFACE. 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 20038797 ↗MalfunctionMay 17, 2024Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem
THE RETAILER REPORTED THAT THE GEL TUBE WAS SPLIT, RUSTED AND GEL WAS LOST. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19340939 ↗MalfunctionApr 19, 2024Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19141140 ↗MalfunctionFeb 23, 2024Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Packaging Problem; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Packaging Problem
IT WAS REPORTED BY DISTRIBUTOR THAT THEY FOUND DENTS AND TUBE PERFORATION AS DEPICTED IN THE PHOTO IN PRIMARY PACKAGE MATERIAL. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18765819 ↗MalfunctionFeb 2, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18632304 ↗MalfunctionJan 12, 2024Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Packaging Problem; Delivered as Unsterile Product; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502911 ↗MalfunctionNov 7, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742266 ↗MalfunctionNov 7, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem
IT WAS REPORTED THAT THE GEL TUBE HAD STAINED AND BUMPED ON THE ALUMINUM TUBE AND SEVEN UNITS WERE AFFECTED. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742253 ↗MalfunctionNov 7, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem
IT WAS REPORTED THAT THERE WAS STAIN FOUND ON ALUMINUM GEL TUBE. THE PRODUCT WAS NOT USED ON PATIENT. THE PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742218 ↗MalfunctionNov 7, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem
IT WAS REPORTED THAT THERE WAS STAIN FOUND ON ALUMINUM GEL TUBE. THE PRODUCT WAS NOT USED ON PATIENT. THE PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742217 ↗MalfunctionMay 25, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE GEL TUBE HAD A STAIN, APPARENTLY IT WAS RUST. 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 14495237 ↗MalfunctionJan 17, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THERE WAS DIRT FOUND ON THE PACKAGE. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13264836 ↗
Other Dressing, Wound, Hydrogel Without Drug And/Or Biologic devices
- Intrasite Gel Applipak 15g USA Ctn 10 66027311Smith & Nephew Medical Limited · Dressing, Wound, Hydrogel Without Drug And/Or Biologic3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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