Integra® MWM8101Recalls & reported problems
Integra Lifesciences Corporation · Integra® MESHED BILAYER WOUND MATRIX 8 in*10 in (20 cm*25 cm) · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780032397), received between Mar 13, 2024 and Apr 19, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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.
Reports received per month
Most reported problems
Device problems
- Device Damaged Prior to Receipt by User1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A PHYSICIAN REPORTED A PATIENT WITH A 4TH DEGREE BURN ON THE LEFT LOWER EXTREMITY DUE TO A MOTOR VEHICLE COLLISION. THE INITIAL APPLICATION OF AN INTEGRA MESHED BILAYER WOUND MATRIX (ID MWM8101) WAS ON (B)(6) 2024. A LOCALIZED INFECTION WAS PRESENT UNDERNEATH THE GRAFT. THE MATRIX WAS REMOVED ON (B)(6) 2024, AND REAPPLIED ON THE SAME DAY. SURFACE AREA WHERE PRODUCT DID NOT INCORPORATE: 315 SQ CM SIZE OF PRODUCT REQUIRED TO REAPPLY TO SURFACE AREA WHERE PRODUCT DID NOT INCORPORATE: 800 SQ CM.
Patient problems: Unspecified Infection
MAUDE report 19143916 ↗MalfunctionMar 13, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
A FACILITY REPORTED THEY RECEIVED A DAMAGED INTEGRA MESHED BILAYER WOUND MATRIX (MWM810), IT LOOKS LIKE WET AND LOOKS LIKE IT WAS HANDLED MULTIPLE TIMES. ALSO, THE EXPIRATION DATE IS A FEW MONTHS AWAY, (B)(6) 2024. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18898261 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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