BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP 8HR L/XL

    MDR report key: 19043557 · Received April 4, 2024

    Report

    Report Number
    3007593958-2024-00018
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 27, 2024
    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 ROOT CAUSE CANNOT BE IDENTIFIED. 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 COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. NO PRODUCT QUALITY RELATED TREND WAS IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. 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 IRRITATIONS. 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 LISTED IN THE HAZARD ANALYSIS (RPT-000097160). 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.

    Description of Event or Problem · 0

    ON 11-MAR-2024, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A MALE CONSUMER (AGE NOT PROVIDED) WHO USED A THERMACARE LOWER BACK & HIP L/XL HEAT WRAP. ON AN UNSPECIFIED DATE IN (B)(6) 2024, THE PATIENT APPLIED A THERMACARE LOWER BACK & HIP L/XL HEAT WRAP TO HIS LOWER BACK FOR PAIN WHILE HE PLAYED GOLF. AFTER USING THE PRODUCT FOR 4 HOURS, THE CONSUMER TOOK THE HEAT WRAP OFF HE REALIZED THAT HE HAD A BURN. THE CONSUMER HAD BEEN TREATED BY A DOCTOR AT AN OUTPATIENT URGENT CARE FACILITY. THE CONSUMER EXPERIENCED A SECOND-DEGREE BURN. THE CONSUMER DID NOT SEE HOW LONG TO HAVE THE PRODUCT ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83777 THERMACARE LOWER BACK & HIP 8HR L/XL HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention