MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX ONLAY PLUS; COLLAGEN DURAL REGENERATION MATRIX

Model Number	DMOP45
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The dmop45 product was placed at an unknown date.It was reported that it collected blood forcing complications and removal.
Additional Manufacturer Narrative
Initial submission was inadvertently submitted to the fda webtrader test account.

• Brand Name: DURAMATRIX ONLAY PLUS
• Common Device Name: COLLAGEN DURAL REGENERATION 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: 13359680
• Report Number: 2249852-2021-00014
• Device Sequence Number: 1751821
• Product Code: GXQ
• UDI-Device Identifier: 00813954021300
• UDI-Public: 00813954021300
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

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: DMOP45
• Device Catalogue Number: DMOP45
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown