V.A.C.® SIMPLACE™ M8275040/5 M8275040/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849554001930), received between Aug 11, 2023 and Mar 15, 2024 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 16-FEB-2024, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI VIA CLINICAL RECORDS: ON 09-JAN-2024, FOREIGN MATERIAL ALLEGED TO BE V.A.C.® SIMPLACE¿ DRESSING WAS STUCK INSIDE THE PATIENT'S WOUND AND BEGAN TO TEAR UPON REMOVAL. THE PHYSICIAN INJECTED PATIENT WITH LIDOCAINE AND USED IRIS SURGICAL SCISSORS TO EXTEND THE WOUND OPENING SLIGHTLY ON THE SUPERIOR EDGE AND LATERALLY. HE THEN REMOVED THE FOREIGN MATERIAL USING "PICK-UPS". NO ADDITIONAL INFORMATION IS AVAILABLE. ON 13-MAR-2024, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® SIMPLACE¿ DRESSING LOT NUMBER A03578V008 WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® SIMPLACE¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18912828 ↗
• InjuryAug 11, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 18-JUL-2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT AND THE PATIENT'S WIFE: ON (B)(6) 2023, THE PATIENT STATED THERE WAS FOREIGN MATERIAL ALLEGED TO BE V.A.C.® SIMPLACE¿ DRESSING LEFT IN THE WOUND THAT WOULD REQUIRE DEBRIDEMENT TO HAVE IT REMOVED. THE PATIENT'S WIFE STATED THE V.A.C.® SIMPLACE¿ DRESSING WAS FOUND IN THE TUNNELED AREA OF THE WOUND. PER CLINICAL RECORD REVIEW: ON (B)(6) 2023, THE HEALTHCARE PROVIDER NOTED "THERE IS RETAINED BLACK FOAM TO THE WOUND BED DEEP INTO THE WOUND BASE. NO SIGNS AND SYMPTOMS OF INFECTION. NO ODOR NOTED. SHARP DEBRIDEMENT WAS PERFORMED TO REMOVE THE DRESSING. VAC THERAPY PLACED ON HOLD." ON 08-AUG-2023, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® SIMPLACE¿ DRESSING LOT NUMBER A11167V009 WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® SIMPLACE¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17513053 ↗