BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP 8HR L/XL 2CT

    MDR report key: 14412310 · Received May 16, 2022

    Report

    Report Number
    3007593958-2022-00031
    Event Type
    Injury
    Date Received
    May 16, 2022
    Date of Event
    April 19, 2022
    Report Date
    May 13, 2022
    Manufacturer
    ANGELINI
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE CANNOT BE IDENTIFIED. THERE IS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER OR RETURN SAMPLE, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. NO PRODUCT QUALITY RELATED TREND 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.

    Description of Event or Problem · 0

    ON 21-APR-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. MEDICAL HISTORY AND USAGE OF CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON 19-APR-2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP TO HER LOWER BACK. TWO HOURS AFTER APPLYING THE HEAT WRAP, SHE EXPERIENCED THAT IT TINGLED. THE HEAT WRAP WAS DIFFICULT TO REMOVE, AND IT BECAME STUCK TO HER. IT LEFT A FLESH BURN. IT WAS ALSO NOTED THAT SHE DEVELOPED A BURN WHICH WAS FURTHER DESCRIBED AS AN ABRASION BURN. THE CONSUMER WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION ABOUT THE DEVICE AND DECLINED TO FURTHER PARTICIPATE IN THE ADVERSE EVENT PROCESS. NO ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387678 THERMACARE LOWER BACK & HIP 8HR L/XL 2CT HOT OR COLD DISPOSABLE PACK. IMD ANGELINI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention