BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTHEAT

    MDR report key: 8674112 · Received June 6, 2019

    Report

    Report Number
    1314800-2019-00030
    Event Type
    Injury
    Date Received
    June 6, 2019
    Report Date
    August 13, 2019
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A CONSUMER STATED THAT SHE HAD ALLEGEDLY RECEIVED BURNS ON HER LOWER BACK WHILE USING A HEATING PAD APPROXIMATELY 6 MONTHS AGO, AND MEDICAL ATTENTION WAS SOUGHT FOR HER INJURIES. SHE STATED THAT SHE RECEIVED SECOND DEGREE BURNS, AND THAT FOLLOW-UP CARE AT A WOUND CLINIC WAS NEEDED. BURNS OF THIS NATURE ARE MOST LIKELY CAUSED BY THE CONSUMER LAYING OR LEANING AGAINST THE PAD WHICH IS CONTRARY TO PROPER USE INSTRUCTION. THE INSTRUCTIONS FOR PROPER USE CLEARLY STATE ""DANGER: IF USED IMPROPERLY, THIS PRODUCT CAN CAUSE SEVERE BURNS TO SKIN, AND DAMAGE TO PROPERTY.", "DO NOT USE WHILE SLEEPING.", AND "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."

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER STATED THAT SHE HAD ALLEGEDLY RECEIVED BURNS ON HER LOWER BACK WHILE USING A HEATING PAD APPROXIMATELY 6 MONTHS AGO, AND MEDICAL ATTENTION WAS SOUGHT FOR HER INJURIES. SHE STATED THAT SHE RECEIVED SECOND DEGREE BURNS, AND THAT FOLLOW-UP CARE AT A WOUND CLINIC WAS NEEDED. BURNS OF THIS NATURE ARE MOST LIKELY CAUSED BY THE CONSUMER LAYING OR LEANING AGAINST THE PAD WHICH IS CONTRARY TO PROPER USE INSTRUCTION. THE INSTRUCTIONS FOR PROPER USE CLEARLY STATE ""DANGER: IF USED IMPROPERLY, THIS PRODUCT CAN CAUSE SEVERE BURNS TO SKIN, AND DAMAGE TO PROPERTY.", "DO NOT USE WHILE SLEEPING.", AND "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 TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469232 SOFTHEAT ELECTRIC HEATING PAD IRT KAZ USA, INC., A HELEN OF TROY COMPANY HP950 14017GMT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R