Cohealyx™ BDCDM1020Recalls & reported problems
Collagen Matrix, Inc. · Collagen Dermal Matrix · Class U
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813954026596), received between Oct 17, 2025 and Oct 17, 2025 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING AN ONGOING CLINICAL STUDY INVOLVING THE COHEALYX PRODUCT, A SERIOUS ADVERSE EVENT OF "GRAFT LOSS" DEEMED POSSIBLY RELATED TO THE PRODUCT WAS NOTED. DETAILS SURROUNDING INITIAL SURGERY WERE NOT SPECIFIED, BUT THE COHEALYX PRODUCT WAS INITIALLY SECURED AND HYDRATED ON (B)(6) 2025. GRAFT PLACEMENT PERFORMED 12 DAYS LATER ON 9/6/2025. THE SERIOUS ADVERSE EVENT OF GRAFT LOSS WAS REPORTED ON (B)(6) 2025. A REGRAFT WAS PERFORMED ON(B)(6) 2025, IN WHICH THE PATIENT'S OWN SKIN (MESHED SPLIT-THICKNESS SKIN GRAFT) AND RECELL (NOT A COLLAGEN MATRIX, INC. PRODUCT) WERE USED. THE COHEALYX PRODUCT WAS NOT EXPLANTED. THE RE-GRAFT WAS COMPLETED SUCCESSFULLY AND THE OUTCOME OF THE INITIAL SERIOUS ADVERSE EVENT WAS REPORTED AS 'RECOVERED/RESOLVED.' NO FURTHER INFORMATION SURROUNDING THE EVENT, PATIENT OUTCOME, OR PATIENT STATUS WILL BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23327523 ↗
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- Cytal® WSM0710Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-125Tei Biosciences 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
- PriMatrix® 607-004-880Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- GIBSON HEALTHCARE 5251-194Benco Dental Supply CO. · Dressing, Wound, Collagen1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.