AQUACEL FOAM PRORecalls & reported problems across all models
Convatec, Purchasing Department · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 6 models of AQUACEL FOAM PRO by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Mar 10, 2022 and Feb 27, 2026 — classified as 51 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AQUACEL FOAM PRO problems
Device problems
- Patient-Device Incompatibility16
- Material Disintegration15
- Material Fragmentation15
- Delivered as Unsterile Product13
- Contamination /Decontamination Problem7
- Unsealed Device Packaging6
- Nonstandard Device5
- Device Damaged Prior to Use3
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Tissue Breakdown16
- Pain2
- Erythema1
AQUACEL FOAM PRO models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AQUACEL FOAM PRO 422358Dressing, Wound, Hydrophilic24 reports
- AQUACEL FOAM PRO 421580Dressing,Wound,Hydrophilic10 reports
- AQUACEL FOAM PRO 422356Dressing, Wound, Hydrophilic8 reports
- AQUACEL FOAM PRO 422357Dressing, Wound, Hydrophilic4 reports
- AQUACEL FOAM PRO 422359Dressing, Wound, Hydrophilic3 reports
- AQUACEL FOAM PRO 421579Dressing,Wound,Hydrophilic2 reports
Recent AQUACEL FOAM PRO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED BY DISTRIBUTOR THAT A CONTAMINANT HAIR WAS OBSERVED. APPROXIMATELY 28 MILLIMETERS OF BLACK, HAIR LIKE MATERIAL WAS FOUND TRAPPED INSIDE THE PRODUCT. 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 24469089 ↗MalfunctionFeb 26, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
IT WAS REPORTED BY DISTRIBUTOR THAT PART OF THE PRIMARY PACKAGE WAS FOUND OPEN. APPROXIMATELY 60 MM (SIXTY MILLIMETER) OF THE SEAL AREA WAS OBSERVED TO BE OPENED AT THE CRIMPED PORTION OF THE PRODUCT. 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 24465995 ↗MalfunctionFeb 16, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION THE PRODUCT WAS FOUND TO BE DAMAGED. THE PRODUCT WAS NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341839 ↗MalfunctionFeb 16, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem
THE DISTRIBUTOR REPORTED THAT DURING INBOUND INSPECTION THE PRODUCT WAS FOUND TO BE DAMAGED. THE PRODUCT WAS NOT USED BY PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341838 ↗MalfunctionAug 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
THE DISTRIBUTOR REPORTED THAT IN AN INBOUND INSPECTION THERE WAS A BLACK SPOT FOUND INSIDE THE DRESSING. THE PRODUCT WAS NOT USED. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22858943 ↗MalfunctionJul 30, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATTER-LIKE CONTAMINANT HAIR INSIDE DRESSING. THE PRODUCT WAS NOT USED BY THE PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22662796 ↗MalfunctionJul 30, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATTER-LIKE CONTAMINANT HAIR INSIDE DRESSING. THE PRODUCT WAS NOT USED BY THE PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22662793 ↗MalfunctionMar 27, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE COMPLAINANT HAD NOTICED A DRAWING ON THE PRODUCT. IT HAD NOT BEEN OPENED OR USED. THE PACKAGE HAD BEEN RECENTLY RECEIVED AT THE SAMPLE WAREHOUSE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21706027 ↗MalfunctionApr 11, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
IT WAS REPORTED THAT THE DRESSING HAD A PACKAGING ISSUE - AN OPENED PACKAGE. THE CUSTOMER DID NOT WISH TO PROVIDE FURTHER INFORMATION. THE PRODUCT WAS NOT USED BY THE PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19094078 ↗MalfunctionDec 21, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS A HAIR INSIDE THE PRIMARY PACKAGING IDENTIFIED DURING THE LABELING PROCESS. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18370750 ↗MalfunctionOct 6, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED BY DISTRIBUTOR THAT THE PATIENT HAD USED THE PRODUCT FOR SOME TIME WHICH WAS UNCLEAR SINCE WHEN. THE DRESSING CHANGE INTERVAL WAS UNKNOWN. IT WAS STATED THAT THE LAST TWO DRESSINGS WERE MORE DIFFICULT TO REMOVE AND PARTIALLY STUCK TO THE WOUND BED WHICH ON CHANGES WERE PAINFUL. THERE WAS PAIN IN THE WOUND BED DURING REMOVAL WHICH DISAPPEARED SHORTLY AFTER REMOVAL. THERE WAS NO BLEEDING. IT WAS UNKNOWN IF WOUND WAS SECRETING LESS. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 17883863 ↗MalfunctionOct 6, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED BY DISTRIBUTOR THAT THE PATIENT HAD USED THE PRODUCT FOR SOME TIME WHICH WAS UNCLEAR SINCE WHEN. THE DRESSING CHANGE INTERVAL WAS UNKNOWN. IT WAS STATED THAT THE LAST TWO DRESSINGS WERE MORE DIFFICULT TO REMOVE AND PARTIALLY STUCK TO THE WOUND BED WHICH ON CHANGES WERE PAINFUL. THERE WAS PAIN IN THE WOUND BED DURING REMOVAL WHICH DISAPPEARED SHORTLY AFTER REMOVAL. THERE WAS NO BLEEDING. IT WAS UNKNOWN IF WOUND WAS SECRETING LESS. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 17883862 ↗MalfunctionJul 19, 2023Nonstandard Device; Nonstandard Device
IT WAS REPORTED BY HEALTHCARE PROFESSIONAL CLINICAL NURSE SPECIALIST THAT THE DRESSING HAD AN ABSORBANCE ISSUE AND EVENT WAS IDENTIFIED ON (B)(6) 2023. ITS EVALUATION HAS BEEN RUNNING IN MANY HEALTHCARE CARE PROVIDER FACILITIES AND HAVE RECEIVED NEGATIVE FEEDBACK. THE PRODUCT WAS USED ON PATIENT, HOWEVER, THERE WAS NO HARM REPORTED FOR MALABSORPTION. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17349788 ↗MalfunctionJul 19, 2023Nonstandard Device; Nonstandard Device
TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17349785 ↗MalfunctionJul 14, 2023Nonstandard Device; Nonstandard Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17325355 ↗
Other Convatec, Purchasing Department products
- DUODERM9 models · 7,142 reports · 1 recall
- SUR-FIT NATURA43 models · 6,207 reports · 2 recalls
- NATURA15 models · 5,161 reports
- CURE CATHETER25 models · 862 reports
- GENTLECATH GLIDE9 models · 572 reports
- ESTEEM52 models · 200 reports · 7 recalls
- ACTIVELIFE21 models · 437 reports · 2 recalls
- GENTLECATH8 models · 430 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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