TheraGenesis Meshed Bilayer Wound Matrix TG-M82120Recalls & reported problems
Gunze Limited · TheraGenesis Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer, and has slits to aid in the drainage of exudate. The collagen sponge layer should be applied to the wound surface. The device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, TheraGenesis Meshed Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis Meshed Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling. · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04967162947207), received between Dec 18, 2025 and Dec 18, 2025 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BURN PATIENT UNDER TREATMENT; DERMAL MATRIX USED; SURGEON OBSERVED THAT THE MATRIX DID NOT PRODUCE THE DESIRED EFFECT, SUSPECTING THERAPEUTIC INEFFECTIVENESS AND TREATMENT DELAY.
Patient problems: Insufficient Information
MAUDE report 23839539 ↗
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- PriMatrix® 607-001-880Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-440Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-125Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- Karl Schumacher TAPE RCWT0001Karl Schumacher Dental Instrument CO., Inc. · Dressing, Wound, Collagen1 recall0 reports
- DermaCol 100 00300ESion Brands LLC · Dressing, Wound, Collagen1 recall0 reports
- DermaCol 100 00300ESion Brands LLC · Dressing, Wound, Collagen1 recall0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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