BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMEND

    MDR report key: 11941053 · Received June 4, 2021

    Report

    Report Number
    2249852-2021-00008
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    January 27, 2021
    Report Date
    June 4, 2021
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    JXI
    UDI-DI
    00813954020174
    PMA / PMN Number
    K060952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833300 NEUROMEND COLLAGEN NERVE WRAP JXI COLLAGEN MATRIX, INC. CNW12050 1712192032 00813954020174

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other