BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE ACCU-THERM HOT PACK

    MDR report key: 8234060 · Received January 10, 2019

    Report

    Report Number
    MW5083032
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    January 4, 2019
    Report Date
    January 9, 2019
    Manufacturer
    UNK
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STAFF WAS IN THE CLEAN UTILITY ROOM WHEN THEY SAW A HOT PACK ON THE FLOOR AND PROCEEDED TO PICK UP. UPON PICKING IT UP, THE HOT PACK BURST IN THEIR HANDS CAUSING MINOR BURNS, BLISTERING ON PALMS AND FINGERS. MEDLINE INDUSTRIES, INC., (B)(4), U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30415 MEDLINE ACCU-THERM HOT PACK PACK, HOT OR COLD, DISPOSABLE IMD UNK 10080196158669

    Patients

    Seq Age Sex Outcome Treatment
    1 Other