BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-THERM

    MDR report key: 7285377 · Received February 21, 2018

    Report

    Report Number
    7285377
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    January 30, 2018
    Report Date
    February 8, 2018
    Manufacturer
    MEDLINE INC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PACK WAS ACTIVATED AND GOT SO HOT IT MELTED PLASTIC. CUT THE PACK OPEN TO CHECK TEMPERATURE AND THERMOMETER ERRORED OUT AFTER 106°.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130396 ACCU-THERM PACK, HOT OR COLD, DISPOSABLE IMD MEDLINE INC. MDS139005 CN17315

    Patients

    Seq Age Sex Outcome Treatment
    1