BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERGRAFT AERIDYAN MATRIX

    MDR report key: 18565646 · Received January 23, 2024

    Report

    Report Number
    3011015097-2024-00002
    Event Type
    Injury
    Date Received
    January 23, 2024
    Report Date
    January 23, 2024
    Manufacturer
    PROSIDYAN, INC.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT THAT HAD BEEN IMPLANTED WITH FIBERGRAFT AERIDYAN HAD AN INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE IS NO EVIDENCE THAT THE INFECTION WAS DUE TO FIBERGRAFT AERIDYAN, BUT THIS COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839635 FIBERGRAFT AERIDYAN MATRIX RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE MQV PROSIDYAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other