V.A.C.® GRANUFOAM™ M8275053/5 M8275053/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00849554002463), received between Oct 9, 2017 and May 24, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT'S FAMILY MEMBER: THE HOME HEALTH AGENCY NURSE HAS NOT SHOWN UP SINCE THE VETERAN AFFAIRS NURSE APPLIED V.A.C.® THERAPY ON (B)(6) 2022. THE PATIENT'S FAMILY MEMBER IS A NURSE AND PERFORMED THE DRESSING CHANGE DUE TO TECHNICAL ISSUES ON (B)(6) 2022. THE FAMILY MEMBER NOTICED V.A.C.® GRANUFOAM¿ DRESSING WAS PLACED ON INTACT SKIN AND ALLEGEDLY A NEW SORE WAS PRESENT WITH SOME REDNESS. ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE CASE MANAGER: THE PATIENT WAS NOTED TO HAVE ALLEGEDLY DEVELOPED NECROTIC TISSUE AND THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS DISCONTINUED. ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PHYSICIAN: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS WORKING JUST FINE AND GRANULATING WELL. WHEN THE PATIENT WAS SEEN LAST WEEK, THE V.A.C.® GRANUFOAM¿ DRESSING WAS PUT ON TOP OF THE LIP OF SKIN AND WHEN V.A.C.® THERAPY WAS TURNED ON AND COMPRESSED CONTINUOUSLY, THERE WAS A LITTLE BIT OF EDGE NECROSIS. THE V.A.C.® GRANUFOAM¿ DRESSING WASN'T CONFINED IN THE WOUND AND WAS OVERSIZED. THE PATIENT'S WOUND

  Patient problems: Necrosis; Skin Inflammation/ Irritation

  MAUDE report 14489521 ↗
• InjuryJul 9, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 08-JUL-2021, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 8993886V011 WAS COMPLETED. ALL END RELEASE TESTING OF THE PRODUCT AND PACKAGING MET SPECIFICATIONS.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12143027 ↗
• InjuryOct 1, 2020Use of Device Problem; Use of Device Problem

  ON 02-OCT-2020, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 8162898V007 WAS COMPLETED. ALL END RELEASE TESTING OF THE PRODUCT AND PACKAGING MET SPECIFICATIONS.

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 10618236 ↗
• InjuryOct 9, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 13 SEP 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE NURSE ALLEGED A FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING WAS ¿STUCK¿ IN THE PATIENT¿S ABDOMINAL WOUND. ON 18 SEP 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE NURSE STATED THE FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING WAS STILL IN THE PATIENT'S WOUND. THE NURSE OBSERVED THE WOUND ON SATURDAY, (B)(6) 2017 AND CONFIRMED THERE WERE NO SIGNS OR SYMPTOMS OF AN INFECTION. THE NURSE INSTRUCTED THE PATIENT TO GO TO THE EMERGENCY ROOM FOR DRESSING REMOVAL. ON 04 OCT 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE PATIENT WAS NON-COMPLIANT AND REFUSED TO GO THE EMERGENCY ROOM. THE PATIENT WANTED TO WAIT UNTIL HIS WOUND CARE APPOINTMENT THIS WEEK. NO ADDITIONAL INFORMATION IS AVAILABLE. A DEVICE HISTORY REVIEW OF LOT NUMBER 3395908 DETERMINED ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 6928037 ↗