V.A.C.® M6275033/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849554003286), received between May 23, 2021 and May 23, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 23-APR-2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT'S FAMILY MEMBER: ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON 23-APR-2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT'S FAMILY MEMBER: THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021, ALLEGEDLY DUE TO AN ISSUE WITH THE WOUND. THE NURSE REPORTEDLY COULD NOT LOCATE A PIECE OF V.A.C. WHITEFOAM¿ DRESSING IN THE WOUND. WHEN THE PATIENT ARRIVED AT THE HOSPITAL, THE V.A.C.® DRESSING WAS REMOVED AND A FOREIGN MATERIAL ALLEGED TO BE V.A.C. WHITEFOAM¿ DRESSING FELL OUT OF THE WOUND CAVITY. THE PATIENT IS IN THE HOSPITAL FOR OBSERVATION. ON 27-APR-2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: THE PATIENT ALLEGEDLY UNDERWENT A BEDSIDE SURGICAL DEBRIDEMENT OF "VERSA FOAM". NO ADDITIONAL INFORMATION AVAILABLE. ON (B)(6) 2021, A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C. WHITEFOAM¿ DRESSING WAS COMPLETED. ALL END RELEASE TESTING OF THE PRODUCT AND PACKAGING MET SPECIFICATIONS.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 11868517 ↗