AQUACEL FOAM PRO 421580Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00768455140503), received between Jul 14, 2022 and Jul 14, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY COMPANY REPRESENTATIVE THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT FIVE DRESSINGS FROM ONE MARKET UNIT HAD LEFT SILICONE RESIDUE ON THE SKIN, AND THUS SHE BELIEVED IT WAS LEAVING RESIDUE IN THE WOUNDS AS WELL. THIS WAS MEANT TO BE USED AS MORE OF A PROTECTIVE DRESSING. THEY HAD BEEN TRIALING THE PRODUCT AS A REPLACEMENT FOR OTHER COMPANY¿S FOAM DRESSING. THREE ATTEMPTS HAVE BEEN MADE AND ONE ELECTRONIC MAIL (EMAIL) WAS SENT REQUESTING FURTHER INFORMATION TO CONTACT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE BUT IT WAS NOT POSSIBLE TO CONTACT HER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15011433 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY COMPANY REPRESENTATIVE THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT FIVE DRESSINGS FROM ONE MARKET UNIT HAD LEFT SILICONE RESIDUE ON THE SKIN, AND THUS SHE BELIEVED IT WAS LEAVING RESIDUE IN THE WOUNDS AS WELL. THIS WAS MEANT TO BE USED AS MORE OF A PROTECTIVE DRESSING. THEY HAD BEEN TRIALING THE PRODUCT AS A REPLACEMENT FOR OTHER COMPANY¿S FOAM DRESSING. THREE ATTEMPTS HAVE BEEN MADE AND ONE ELECTRONIC MAIL (EMAIL) WAS SENT REQUESTING FURTHER INFORMATION TO CONTACT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE BUT IT WAS NOT POSSIBLE TO CONTACT HER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15011431 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY COMPANY REPRESENTATIVE THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT FIVE DRESSINGS FROM ONE MARKET UNIT HAD LEFT SILICONE RESIDUE ON THE SKIN, AND THUS SHE BELIEVED IT WAS LEAVING RESIDUE IN THE WOUNDS AS WELL. THIS WAS MEANT TO BE USED AS MORE OF A PROTECTIVE DRESSING. THEY HAD BEEN TRIALING THE PRODUCT AS A REPLACEMENT FOR OTHER COMPANY¿S FOAM DRESSING. THREE ATTEMPTS HAVE BEEN MADE AND ONE ELECTRONIC MAIL (EMAIL) WAS SENT REQUESTING FURTHER INFORMATION TO CONTACT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE BUT IT WAS NOT POSSIBLE TO CONTACT HER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15011430 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY COMPANY REPRESENTATIVE THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT FIVE DRESSINGS FROM ONE MARKET UNIT HAD LEFT SILICONE RESIDUE ON THE SKIN, AND THUS SHE BELIEVED IT WAS LEAVING RESIDUE IN THE WOUNDS AS WELL. THIS WAS MEANT TO BE USED AS MORE OF A PROTECTIVE DRESSING. THEY HAD BEEN TRIALING THE PRODUCT AS A REPLACEMENT FOR OTHER COMPANY¿S FOAM DRESSING. THREE ATTEMPTS HAVE BEEN MADE AND ONE ELECTRONIC MAIL (EMAIL) WAS SENT REQUESTING FURTHER INFORMATION TO CONTACT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE BUT IT WAS NOT POSSIBLE TO CONTACT HER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15011429 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY COMPANY REPRESENTATIVE THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT FIVE DRESSINGS FROM ONE MARKET UNIT HAD LEFT SILICONE RESIDUE ON THE SKIN, AND THUS SHE BELIEVED IT WAS LEAVING RESIDUE IN THE WOUNDS AS WELL. THIS WAS MEANT TO BE USED AS MORE OF A PROTECTIVE DRESSING. THEY HAD BEEN TRIALING THE PRODUCT AS A REPLACEMENT FOR OTHER COMPANY¿S FOAM DRESSING. THREE ATTEMPTS HAVE BEEN MADE AND ONE ELECTRONIC MAIL (EMAIL) WAS SENT REQUESTING FURTHER INFORMATION TO CONTACT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE BUT IT WAS NOT POSSIBLE TO CONTACT HER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15011428 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY COMPANY REPRESENTATIVE THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT FIVE DRESSINGS FROM ONE MARKET UNIT WERE NOT AS ABSORPTIVE AS THE OTHER COMPANY'S DRESSING AND LEFT THE WOUND WITH AREAS OF MACERATION. THEY HAD BEEN TRIALING THE PRODUCT AS A REPLACEMENT FOR OTHER COMPANY¿S FOAM DRESSING. THREE ATTEMPTS HAVE BEEN MADE AND ONE ELECTRONIC MAIL (EMAIL) WAS SENT REQUESTING FURTHER INFORMATION TO CONTACT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE BUT IT WAS NOT POSSIBLE TO CONTACT HER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: Tissue Breakdown

  MAUDE report 15011388 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY COMPANY REPRESENTATIVE THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT FIVE DRESSINGS FROM ONE MARKET UNIT WERE NOT AS ABSORPTIVE AS THE OTHER COMPANY'S DRESSING AND LEFT THE WOUND WITH AREAS OF MACERATION. THEY HAD BEEN TRIALING THE PRODUCT AS A REPLACEMENT FOR OTHER COMPANY¿S FOAM DRESSING. THREE ATTEMPTS HAVE BEEN MADE AND ONE ELECTRONIC MAIL (EMAIL) WAS SENT REQUESTING FURTHER INFORMATION TO CONTACT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE BUT IT WAS NOT POSSIBLE TO CONTACT HER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: Tissue Breakdown

  MAUDE report 15011385 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY COMPANY REPRESENTATIVE THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT FIVE DRESSINGS FROM ONE MARKET UNIT WERE NOT AS ABSORPTIVE AS THE OTHER COMPANY'S DRESSING AND LEFT THE WOUND WITH AREAS OF MACERATION. THEY HAD BEEN TRIALING THE PRODUCT AS A REPLACEMENT FOR OTHER COMPANY¿S FOAM DRESSING. THREE ATTEMPTS HAVE BEEN MADE AND ONE ELECTRONIC MAIL (EMAIL) WAS SENT REQUESTING FURTHER INFORMATION TO CONTACT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE BUT IT WAS NOT POSSIBLE TO CONTACT HER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: Tissue Breakdown

  MAUDE report 15011382 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY COMPANY REPRESENTATIVE THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT FIVE DRESSINGS FROM ONE MARKET UNIT WERE NOT AS ABSORPTIVE AS THE OTHER COMPANY'S DRESSING AND LEFT THE WOUND WITH AREAS OF MACERATION. THEY HAD BEEN TRIALING THE PRODUCT AS A REPLACEMENT FOR OTHER COMPANY¿S FOAM DRESSING. THREE ATTEMPTS HAVE BEEN MADE AND ONE ELECTRONIC MAIL (EMAIL) WAS SENT REQUESTING FURTHER INFORMATION TO CONTACT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE BUT IT WAS NOT POSSIBLE TO CONTACT HER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: Tissue Breakdown

  MAUDE report 15011381 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY COMPANY REPRESENTATIVE THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT FIVE DRESSINGS FROM ONE MARKET UNIT WERE NOT AS ABSORPTIVE AS THE OTHER COMPANY'S DRESSING AND LEFT THE WOUND WITH AREAS OF MACERATION. THEY HAD BEEN TRIALING THE PRODUCT AS A REPLACEMENT FOR OTHER COMPANY¿S FOAM DRESSING. THREE ATTEMPTS HAVE BEEN MADE AND ONE ELECTRONIC MAIL (EMAIL) WAS SENT REQUESTING FURTHER INFORMATION TO CONTACT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE BUT IT WAS NOT POSSIBLE TO CONTACT HER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: Tissue Breakdown

  MAUDE report 15011380 ↗