BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 21510108 · Received March 3, 2025

    Report

    Report Number
    3007593958-2025-00005
    Event Type
    Injury
    Date Received
    March 3, 2025
    Report Date
    February 25, 2025
    Manufacturer
    BRIDGES CONSUMER HEALTHCARE
    Product Code
    IMD
    UDI-DI
    00305733010396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOST PROBABLE ROOT CAUSE IS INTENTIONAL DEVICE MISUSE. THE CONSUMER USED A THERMACARE LBH HEAT WRAP ON HER STOMACH FOR STOMACH PAIN, NOT USING THE WRAP BELTS TO SECURE THE WRAP, JUST TUCKED INTO HER INTO THE FRONT OF HER LEGGINGS. THE THERMACARE LABELING AND INSTRUCTIONS FOR USE PROVIDE GUIDANCE FOR THE CUSTOMER TO PREVENT INJURY DURING USE. IN THIS CASE, THE CUSTOMER USED A LBH WRAP ON HER STOMACH FOR STOMACH PAIN. LABELING STATES THERMACARE LBH PROVIDES HEAT THERAPY FOR TEMPORARY RELIEF OF MINOR MUSCULAR AND JOINT ACHES AND PAINS ASSOCIATED WITH OVEREXERTION, STRAINS, SPRAINS, AND ARTHRITIS. THERMACARE LBH DIRECTIONS STATE THAT THE LBH WRAP IS APPLIED ON LOWER BACK OR HIP WITH DARKER HEAT CELLS TOWARDS SKIN, AND TO PLACE THE WRAP FLAT, DO NOT FOLD OR BUNCH AS YOUR RISK IS INCREASED (FOR RECEIVING A BURN). THE PACKAGING INSTRUCTION WARNS THE CONSUMER, DO NOT PLACE EXTRA PRESSURE OVER THE PRODUCT SUCH AS LEANING AGAINST HARD SURFACES, OR WEARING UNDER TIGHT CLOTHING, A TIGHT WAIST BAND OR BELT. THIS IS AN ADVERSE EVENT FOR A BURN AND A RISK CALCULATION CANNOT BE DETERMINED AS THERE IS NO REASONABLE SUGGESTION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A SPONTANEOUS REPORT WAS RECEIVED VIA SOCIAL MEDIA REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) WHO USED A THERMACARE LOWER BACK & HIP HEAT WRAP. ON (B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED ONE THERMACARE LOWER BACK & HIP HEAT WRAP ON HER STOMACH FOR STOMACH PAIN RELIEF. IT WAS CLARIFIED THAT SHE THOUGHT SHE FOLDED THE HEAT WRAP IN HALF AND THE HEAT WRAP WAS THEN TUCKED INTO THE FRONT OF HER LEGGINGS. AFTER USING THE PRODUCT, SHE EXPERIENCED A BURN AND A BLISTER FROM IT BURNING HER SKIN. IT TURNED INTO A BLOOD BLISTER WHICH WAS PAINFUL. SHE KEPT IT COVERED WITH A BAND AID. AS OF (B)(6) 2025, HER BLOOD BLISTER WAS HEALING, AND SHE NOTED SHE MAY HAVE A SCAR FROM IT. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635012 THERMACARE LOWER BACK & HIP HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE GA1132 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention