AQUACEL FOAM PRO 422358Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00768455157334), received between May 7, 2022 and Jul 30, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSINGS 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 15011566 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSING 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 15011564 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSINGS 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 15011562 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSINGS 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 15011561 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSINGS 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 15011560 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Tissue Breakdown

  MAUDE report 15011559 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSING WERE NOT AS ABSORPTIVE AS THE OTHER COMPANY'S DRESSING AND LEFT THE WOUND WITH AREAS OF MACERATION. THEY HAD BEEN TRAILING 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 15011557 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSINGS 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 15011555 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSING 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 15011554 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSINGS 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 15011553 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSINGS 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 15011552 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSING 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 15011551 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY (B)(6) SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSINGS 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 15011548 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSINGS 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 15011547 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSING 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 15011546 ↗
• MalfunctionJul 14, 2022Material Disintegration; Material Fragmentation; Material Disintegration; Material Fragmentation

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSINGS 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 15011544 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY (B)(6) SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSING 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 15011543 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSING 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 15011482 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSING 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 15011480 ↗
• MalfunctionJul 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY REGIONAL CLINICAL SPECIALIST FOR COMPANY THAT THE WOC (WOUND, OSTOMY, AND CONTINENCE) NURSE TOLD HIM THAT TEN DRESSINGS FROM ONE MARKET UNIT THE DRESSING WERE NOT AS ABSORPTIVE AS THE OTHER COMPANY'S DRESSING AND LEFT THE WOUND WITH AREAS OF MACERATION. THEY HAD BEEN TRAILING 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 15011477 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Patient-Device Incompatibility; Fluid/Blood Leak; Patient-Device Incompatibility

  THE SALES REPRESENTATIVE RAISED THE ISSUE REPORTED BY TISSUE VIABILITY NURSE (TVN) IN LEG ULCER CLINIC VIA ELECTRONIC MAIL (EMAIL) THAT THE END USER HAD AN ADVERSE REACTION AND THE TRIAL WAS STOPPED WITH HIM ON MONDAY (FOURTEENTH OF MARCH). IT WAS REPORTED THAT THERE WAS INCREASE IN EXUDATE, REDNESS, TISSUE DAMAGE AND MACERATION OF CHRONIC WOUND WITH REGRESSION MALODOR DUE TO WHICH THE TRIAL WAS STOPPED. IT WAS ALSO REPORTED THAT THE EXUDATE HAD STRIKE THROUGH TO THE OUTER LAYER OF THE BANDAGE AND THERE WAS MALODOR REPORTED. THE DRESSING WAS COMPLETELY SATURATED AS WELL AS THE BANDAGES AND SKIN WAS COMPLETELY MACERATED. PATIENT WAS PREVIOUSLY TREATED ON TWENTY EIGHTH OF FEBRUARY WITH OTHER COMPANY'S ANTIMICROBIAL BARRIER PROTECTION BANDAGES AS WELL AS ANOTHER COMPANY'S DRESSINGS. THE DURATION OF USE WAS FOUR DAYS. ON THIRD OF MARCH, END USER WAS RE-DOPPLERED AND EVERYTHING WAS FINE AND ANOTHER COMPANY'S ANTIMICROBIAL BARRIER PROTECTION BANDAGES WERE APPLIED. ON SEVENTH OF MARCH END USER WAS RE-DOPPLERED AND APPLIED COMPANY'S DRESSING. ON TENTH OF MARCH, SKIN WAS MACERATED AND ODOR WAS OBSERVED. IT WAS WASHED IN WOUND IRRIGATION SOLUTION AND ANTI-BIOTIC TOPICAL CREAM AND COMPANY'S D

  Patient problems: Erythema; Tissue Breakdown

  MAUDE report 14314604 ↗