V.A.C.® SIMPLACE™ M8275045/5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849554001350), received between Oct 8, 2020 and Oct 22, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 01-OCT-2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT: V.A.C.® THERAPY WAS PLACED ON HOLD FOR TWO WEEKS DUE TO A FUNGAL INFECTION, ALLEGEDLY RELATED TO THE V.A.C.® DRAPE. ON 02-OCT-2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT: ON (B)(6) 2024, V.A.C.® THERAPY WAS REMOVED DUE TO AN ALLEGED FUNGAL INFECTION. HER SKIN WAS SWEATING AND SHE IS NOT SURE IF THE IRRITATION WAS CAUSED BY THE V.A.C.® DRAPE, OR THE V.A.C.® TUBING RUBBING AGAINST HER SKIN. ON 07-OCT-2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE NURSE: V.A.C.® THERAPY WAS PLACED ON HOLD DUE TO A PERIWOUND FUNGAL INFECTION THAT WAS TREATED WITH NYSTATIN POWDER. THERE IS NO EVIDENCE OF V.A.C.® TUBING RUBBING AGAINST PATIENT¿S SKIN; PHOTOS DISPLAY A FUNGAL RASH TO THE AREA COVERED BY THE V.A.C.® DRAPE AND THERE IS DOCUMENTATION THAT A FUNGAL ODOR WAS PRESENT. V.A.C.® THERAPY HAS REMAINED ON HOLD AND FUNGAL INFECTION HAS RESOLVED. ON 22-OCT-2024, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER A09429V005 AND ASSOCIATED V.A.C.® DRAPE WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT RETURNED; THEREF

  Patient problems: Fungal Infection

  MAUDE report 20508578 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10-DEC-2020, A DEVICE HISTORY RECORD WAS COMPLETED FOR V.A.C.® SIMPLACE¿ EX DRESSING LOT NUMBER 60254438V005. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. ON 08-JAN-2021, QUALITY ENGINEERING COMPLETED AN EVALUATION OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. ON 29-SEP-2020, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS BEFORE PLACEMENT WITH THE PATIENT. ON (B)(6) 2020, THE DEVICE WAS PLACED WITH THE PATIENT. ON 06-JAN-2021, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI QUALITY ENGINEERING AND PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION OF THE UNIT.

  Patient problems: Fungal Infection

  MAUDE report 11042306 ↗
• InjuryOct 8, 2020Use of Device Problem; Use of Device Problem

  ON 11-SEP-2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2020, THE V.A.C.® SIMPLACE¿ EX DRESSING WAS PLACED IN THE WOUND. ON (B)(6) 2020, A FOREIGN MATERIAL ALLEGED TO BE V.A.C.® SIMPLACE¿ EX DRESSING WAS ADHERED TO THE PATIENT'S WOUND AND DID NOT COME OUT AFTER SOAKING THE WOUND. ON (B)(6) 2020, THE PHYSICIAN SURGICALLY REMOVED THE FOREIGN MATERIAL. ON (B)(6) 2020, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® SIMPLACE¿ EX DRESSING LOT NUMBER 60238303V005 WAS COMPLETED. ALL END RELEASE TESTING OF THE PRODUCT AND PACKAGING MET SPECIFICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 10650830 ↗