BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP L/XL 8HR

    MDR report key: 18060439 · Received November 2, 2023

    Report

    Report Number
    3007593958-2023-00069
    Event Type
    Injury
    Date Received
    November 2, 2023
    Report Date
    November 2, 2023
    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 SITE INVESTIGATED THIS COMPLAINT BY REVIEWING THE DEVICE HISTORY RECORDS AND MANUFACTURING CONTROLS. THE REVIEW OF THE DEVICE HISTORY RECORDS, BATCH THERMAL RECORDS, AND PRODUCTION CONTROLS MET THE PRODUCT RELEASE CRITERIA. CONSUMER REPORTS A BURN. THE CAUSE OF THE CONSUMER A BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE A BURN LISTED IN THE HAZARD ANALYSIS ((B)(4)). IN ADDITION TO THESE HAZARDS, THERE ARE MULTIPLE RISKS THAT ARE OUTSIDE 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 RISKS AND RELAY THE APPROPRIATE INSTRUCTIONS FOR USE TO OUR CUSTOMERS TO AVOID BURNS, BLISTERS AND SKIN IRRITATIONS. 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 16-OCT-2023, A SPONTANEOUS REPORT WAS RECEIVED FROM THE UNITED STATES VIA EMAIL REGARDING A FEMALE (AGE NOT PROVIDED) WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. ON AN UNSPECIFIED DATE, THE CONSUMER APPLIED ONE THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP FOR AN UNSPECIFIED DATE. ON AN UNSPECIFIED DATE AFTER 4 HOURS OF USE, THE CONSUMER EXPERIENCED A QUARTER-SIZED BURN WHICH WAS DEEP. SHE WENT TO AN EMERGENCY ROOM AND IS SEEING A WOUND CARE SPECIALIST. THE CONSUMER DECLINED TO PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209365 THERMACARE LOWER BACK & HIP L/XL 8HR HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE GA0411 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention