BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE LOWER BACK & HIP L/XL

    MDR report key: 19072748 · Received April 9, 2024

    Report

    Report Number
    3007593958-2024-00021
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 2, 2024
    Report Date
    April 9, 2024
    Manufacturer
    BRIDGES CONSUMER HEALTHCARE
    Product Code
    IMD
    UDI-DI
    00305733010396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE CANNOT BE IDENTIFIED. 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 THE WRAP BECAME TOO HOT. THE CAUSE OF THE CONSUMER STATING THE WRAP BECAME TOO HOT IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE A WRAP TO BE TOO HOT 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.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIS TELEPHONE REGARDING A 45-YEAR-OLD MALE WHO USED A THERMACARE LOWER BACK AND HIP L/XL HEAT WRAP. ON APPROXIMATELY ON (B)(6) 2024, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP L/XL HEAT WRAP FOR AN UNSPECIFIED INDICATION. ON AN UNSPECIFIED TIME AFTER APPLICATION OF THE PRODUCT, THE CONSUMER REMOVED THE PRODUCT BECAUSE IT BECAME TOO HOT. NO INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539145 THERMACARE LOWER BACK & HIP L/XL HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE GA0936 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention