BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GTA INFRARED HEATING PAD

    MDR report key: 8396594 · Received March 6, 2019

    Report

    Report Number
    MW5084706
    Event Type
    Injury
    Date Received
    March 6, 2019
    Date of Event
    November 12, 2018
    Report Date
    December 10, 2018
    Manufacturer
    UNKNOWN
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CALLER SAYS THAT SHE PULLED A MUSCLE UNDER HER ARM AND DECIDED TO USE THE HEATING PAD. AFTER ABOUT 20 MINUTES SHE REMOVED THE HEATING PAD AND HAD BLISTERS ALL OVER HER CHEST, BACK, AND UNDER HER ARM. CONTACTED (B)(6) WHO INFORMED THE CALLER THAT THE HEATING PAD SHOULD NOT BE ABLE TO GET HOT ENOUGH TO BURN THE SKIN. REQUESTED THAT SHE RETURN THE PRODUCT AND THEY WILL PROVIDE HER WITH A CREDIT. CALLER RECEIVED MEDICAL ATTENTION AT LOCAL HOSPITAL. BELIEVES SHE MAY HAVE SEVERE NERVE DAMAGE FROM THE BURNS. CALLER BELIEVES THIS PRODUCT IS A BURN HAZARD. PRODUCT TYPE: COMFORT AND RELAXATION. RETAILER: (B)(6). PURCHASE DATE: (B)(6) 2018. THIS DATE IS AN ESTIMATE. CALLER STILL HAS THE PRODUCT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186594 GTA INFRARED HEATING PAD PAD, HEATING, POWERED IRT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention