BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONARY CUSTOM PACK

    MDR report key: 2992406 · Received February 27, 2013

    Report

    Report Number
    2992406
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 27, 2013
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WENT INTO LAB AND WHEN PULLING OUT LINEN FROM THE CABINET IT WAS NOTICED A PERFORATION IN ONE OF OUR PACKS. STERILE PACK REMOVED FROM CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83637 CORONARY CUSTOM PACK KIT KDD AVID MEDICAL, INC. ORHS031-17 865671

    Patients

    Seq Age Sex Outcome Treatment
    1 *