BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 11869649 · Received May 24, 2021

    Report

    Report Number
    11869649
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 11, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF RN WAS TRYING TO ACTIVATE THE HEAT PACK. THE CHEMICALS GOT ON HER SKIN AND CLOTHING. NO ADVERSE EFFECTS REPORTED. DID NOT COME INTO CONTACT WITH ANY PATIENT. MANUFACTURER RESPONSE FOR HOT PACK INSTANT, (BRAND NOT PROVIDED) (PER SITE REPORTER). PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769578 CARDINAL HEALTH PACK, HOT OR COLD, DISPOSABLE IMD CARDINAL HEALTH 200, LLC 11443-012B

    Patients

    Seq Age Sex Outcome Treatment
    1