MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. COHEALYX; BOVINE DERMIS COLLAGEN DERMAL MATRIX

Model Number	BDCDM1020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: COHEALYX
• Common Device Name: BOVINE DERMIS COLLAGEN DERMAL MATRIX
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 23327523
• Report Number: 2249852-2025-00041
• Device Sequence Number: 10638090
• Product Code: KGN
• UDI-Device Identifier: 00813954026596
• UDI-Public: (01)00813954026596(17)271130(10)BDCDM241001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K243071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: BDCDM1020
• Device Catalogue Number: BDCDM1020
• Device Lot Number: BDCDM241001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female