Integra® MWM4051Recalls & reported problems
Integra Lifesciences Corporation · Integra® MESHED BILAYER WOUND MATRIX 4 in*5 in (10 cm*12.5 cm) · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780032373), received between Nov 15, 2024 and Apr 21, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJan 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MalfunctionNov 15, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
A FACILITY REPORTED THAT UPON OPENING AN INTEGRA MESHED BILAYER WOUND MATRIX (ID MWM4051) A LEAKING HOLE IN THE INNER PACKAGING WAS FOUND. THE PRODUCT WAS NOT USED AND THE EVENT DID NOT LED TO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20694730 ↗
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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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