BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 10648922 · Received October 7, 2020

    Report

    Report Number
    MW5097145
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 18, 2020
    Report Date
    October 5, 2020
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    FTM
    UDI-DI
    00859389005034
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS WAS AN INITIAL IMPLANT OF A PACEMAKER: THE SCRUB TECH OPENED AND PREPARED THE EQUIPMENT PER MANUFACTURER'S INSTRUCTIONS WHILE IN THE ROOM WITH THE PHYSICIAN. AFTER THE PREPARATION TIME, THE DEVICE POUCH WAS HANDED TO THE IMPLANTING PHYSICIAN. AT THIS TIME THE PHYSICIAN ATTEMPTED TO OPEN THE DEVICE FOR USE. THE SUTURES THAT ARE ATTACHED TO THE DEVICE IN PACKAGING BEGAN TO DISSOLVE/FALL AWAY FROM THE POUCH OPENING. SUBSEQUENTLY, THE POUCH SEPARATED ON ITSELF AND WAS NOT DEEMED USABLE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104750 CANGAROO ENVELOPE MESH, SURGICAL FTM AZIYO BIOLOGICS, INC. CMCV-009-MED M19D1171050 00859389005034

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR