BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTHEAT

    MDR report key: 5147841 · Received October 7, 2015

    Report

    Report Number
    1314800-2015-00071
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    September 10, 2015
    Report Date
    October 7, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER STATED THAT SHE HAD ALLEGEDLY RECEIVED BURNS ON HER BACK WHILE USING A HEATING PAD, AND THAT MEDICAL ATTENTION WAS REQUIRED FOR HER INJURIES. THE CONSUMER ALSO ALLEGES THAT THE AUTOMATIC SHUT OFF FEATURE DID FUNCTION PROPERLY WHEN THE INCIDENT OCCURRED. THE CONSUMER STATED THAT SHE WAS LAYING ON THE HEATING PAD WHEN THE INCIDENT OCCURRED. THE INSTRUCTIONS FOR PROPER USE CLEARLY STATE NOT TO USE THIS PRODUCT WHILE SLEEPING. IT ALSO STATES, "THIS HEATING PAD IS INTENDED FOR USE ON TOP OF YOUR BODY. DO NOT SIT OR LIE ON TOP OF THE HEATING PAD. NEVER PLACE PAD BETWEEN YOURSELF AND CHAIR, SOFA, BED OR PILLOW." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR LAB ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664297 SOFTHEAT IRT KAZ USA, INC. HP-980 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention