BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 11946193 · Received June 7, 2021

    Report

    Report Number
    11946193
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 17, 2021
    Report Date
    May 24, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ACTIVATION, CARDINAL HEALTH" INSTANT HOT PACK BAG EXPLODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842954 CARDINAL HEALTH PACK, HOT OR COLD, DISPOSABLE IMD CARDINAL HEALTH 200, LLC 11443-012B V1B241

    Patients

    Seq Age Sex Outcome Treatment
    1