BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP L/XL 8HR

    MDR report key: 23744183 · Received December 8, 2025

    Report

    Report Number
    3007593958-2025-00037
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 22, 2025
    Report Date
    December 5, 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

    THERE IS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETE FOR THE WRAP INVOLVED IN THIS CASE. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID THE RISK OF BLISTERS AND OTHER SKIN IRRITATION. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE PACKAGED PRODUCT QUALITY. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE A BURN/BLISTER LISTED IN THE HAZARD ANALYSIS (RPT-000097160). IN ADDITION TO THESE HAZARDS, THERE ARE MULTIPLE RISKS THAT ARE OUTSIDE OF THE CONTROL OF THE SITE. THESE INCLUDE THINGS LIKE AGE, SKIN CONDITION, MEDICAL CONDITIONS, DEVICE USE ERROR AND OFF-LABEL USE. THE WARNING LABELS ON OUR PRODUCT ARE USED TO ADDRESS THESE RISK AND RELAY THE APPROPRIATE INSTRUCTIONS FOR USE TO OUR CUSTOMERS TO AVOID BURNS, BLISTERS AND SKIN IRRITATIONS.

    Description of Event or Problem · 0

    ON 24-NOV-2025, THIS SPONTANEOUS REPORT WAS RECEIVED VIA EMAIL REGARDING A 59-YEAR-OLD FEMALE IN THE U.S. IN ASSOCIATION WITH A THERMACARE LOWER BACK & HIP L/XL HEAT WRAP. ON (B)(6) 2025, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK & HIP L/XL HEAT WRAP ON THE LEFT SIDE OF HER BACK AND WAIST AREA. AFTER WEARING THE PRODUCT FOR APPROXIMATELY 8 HOURS, SHE EXPERIENCED BURN MARKS ON HER SKIN, SORENESS, RAW SKIN, AND IRRITATION. ON (B)(6) 2025, THE AREA WAS SCABBING OVER AND CONTINUED TO BE SORE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437337 THERMACARE LOWER BACK & HIP L/XL 8HR HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention UNSPECIFIED MEDICATION FOR BLOOD PRESSURE.