BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTHEAT

    MDR report key: 5161852 · Received October 14, 2015

    Report

    Report Number
    MW5057219
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    October 14, 2015
    Report Date
    October 14, 2015
    Manufacturer
    KAZ
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY (B)(6) DAUGHTER RECEIVED SHOCKS FROM A HEATING PAD. SHE SCREAMED, TOOK IT OFF OF HER, WAS INCONTINENT OF URINE, AND FOUND THE ON/OFF SWITCH WAS SMOKING. IT WAS UNPLUGGED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678916 SOFTHEAT SOFTHEAT IRT KAZ HP980 JHP980SMT

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention