V.A.C.® SIMPLACE™ M8275041/5 M8275041/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849554001947), received between Feb 26, 2020 and Feb 26, 2020 — classified as 1 injury.

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

• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2020, THE PATIENT'S SKIN GRAFT WAS ALLEGEDLY REMOVED WHEN THE NURSE CHANGED THE V.A.C.® SIMPLACE¿ DRESSING. ON 06-FEB-2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE GRAFT WAS REAPPLIED ON (B)(6) 2020 AND V.A.C.® THERAPY RESUMED. ON 18-FEB-2020, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® SIMPLACE¿ DRESSING LOT NUMBER 6829990V007 WAS COMPLETED. ALL END RELEASE TESTING OF THE PRODUCT AND PACKAGING MET SPECIFICATIONS. A DEVICE EVALUATION OF ACTIV.A.C.¿ THERAPY UNIT IS CURRENTLY PENDING COMPLETION.

  Patient problems: Failure of Implant

  MAUDE report 9760211 ↗