BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP L/XL

    MDR report key: 17714363 · Received September 8, 2023

    Report

    Report Number
    3007593958-2023-00058
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 14, 2023
    Report Date
    September 8, 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 (B)(6) 2023, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL FROM A CONSUMER REGARDING A 54-YEAR-OLD MALE CONSUMER WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. ON (B)(6) 2023, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP TO THE LEFT HIP FOR AN UNSPECIFIED INDICATION. AFTER USING THE HEAT WRAP FOR 30 MINUTES, HE EXPERIENCED A BURN ON HIS LEFT HIP. AS OF (B)(6)2023, THE SITE WAS RED AND HE HAD A BLISTER THAT HAD NOT OPENED. FOR TREATMENT, NEOSPORIN WAS APPLIED. THE CONSUMER DID NOT SEE A HEALTH CARE PRACTITIONER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525334 THERMACARE LOWER BACK & HIP L/XL HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE EE3308 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention PAIN MEDICATION