MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. NEUROMEND; COLLAGEN NERVE WRAP

Model Number	CNW12050
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a neuromend device with an expiration date of december 31, 2020 was implanted on (b)(6) 2021.There has been no additional information provided.

• Brand Name: NEUROMEND
• Common Device Name: COLLAGEN NERVE WRAP
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 11941053
• Report Number: 2249852-2021-00008
• Device Sequence Number: 1085349
• Product Code: JXI
• UDI-Device Identifier: 00813954020174
• UDI-Public: 00813954020174
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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
• Operator of Device: No Information
• Device Expiration Date: 12/31/2020
• Device Model Number: CNW12050
• Device Catalogue Number: CNW12025
• Device Lot Number: 1712192032
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR