BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERGRAFT BG MATRIX

    MDR report key: 18310226 · Received December 12, 2023

    Report

    Report Number
    3011015097-2023-00050
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    October 19, 2023
    Report Date
    December 11, 2023
    Manufacturer
    PROSIDYAN, INC.
    Product Code
    MQV
    PMA / PMN Number
    K180080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER ON NOVEMBER 14, 2023 THAT THERE WAS SOME DRAINAGE FROM THE WOUND. BASED ON THE PROVIDED PHOTO OF THE WOUND, THERE IS NO INDICATION THAT THE DEVICE CAUSED THE DRAINAGE. A ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. HOWEVER, IN ABUNDANCE OF CAUTION THIS EVENT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777921 FIBERGRAFT BG MATRIX RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE MQV PROSIDYAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other