BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2871349 · Received December 6, 2012

    Report

    Report Number
    1314800-2012-00054
    Event Type
    Other
    Date Received
    December 6, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 3, 2012
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING 3RD DEGREE BURNS FROM THE HEATING PAD. SHE STATED THIS IS THE SECOND TIME SHE HAS RECEIVED BURNS FROM THE HEATING PAD. BURNS OF THE NATURE ARE CAUSED BY THE CONSUMER LAYING OR LEANING AGAINST THE HEATING PAD WHICH IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ, INC. HP710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other