BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP

    MDR report key: 17021133 · Received May 30, 2023

    Report

    Report Number
    3007593958-2023-00030
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 22, 2023
    Manufacturer
    ANGELINI
    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.

    Description of Event or Problem · 0

    ON 04-MAY-2023 A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A FEMALE (AGE WAS NOT PROVIDED) WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON (B)(6) 2023, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP AND WORE IT OVERNIGHT. AFTER 9 HOURS OF WEARING THE HEAT WRAP, THE CONSUMER REMOVED IT AND SHE NOTICED SHE HAD A SMALL BURN. THE CONSUMER DECLINED TO PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436751 THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP HOT OR COLD DISPOSABLE PACK. IMD ANGELINI BP0466 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention