BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTHEAT

    MDR report key: 4964051 · Received July 30, 2015

    Report

    Report Number
    1314800-2015-00060
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 30, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER STATED THAT SHE HAD ALLEGEDLY RECEIVED 2ND AND 3RD DEGREE BURNS ON HER SHOULDER WHILE USING A HEATING PAD, AND THAT MEDICAL ATTENTION WAS REQUIRED FOR HER INJURIES. THE CONSUMER STATED THAT SHE WAS SITTING AGAINST THE HEATING PAD AND THAT SHE MAY HAVE FALLEN ASLEEP 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, BUT THE CONSUMER STATED SHE NO LONGER HAD THE PRODUCT IN HER POSSESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495870 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP-980 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R