BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 13450681 · Received February 4, 2022

    Report

    Report Number
    13450681
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 28, 2022
    Report Date
    February 1, 2022
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    FTM
    UDI-DI
    00859389005072
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CANGANROO POUCH DISINTEGRATED ON ATTEMPTED INSERTION INTO AICD (AUTOMATIC IMPLANTABLE CARDIAC DEFIBRILLATOR) POCKET. AFTER ABX (ANTIBIOTIC) SOAK. REMOVED INTACT. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649269 CANGAROO ENVELOPE MESH, SURGICAL FTM AZIYO BIOLOGICS, INC. CMCV-009-XLG M20M1348034 00859389005072

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA Male