BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15004792 · Received July 13, 2022

    Report

    Report Number
    3007593958-2022-00043
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    June 26, 2022
    Report Date
    July 12, 2022
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 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 (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE FROM A 77-YEAR-OLD MALE WHO USED A THERMACARE LOWER BACK AND HIP L/XL 8HR HEAT WRAP. MEDICAL HISTORY INCLUDE PAIN. FURTHER MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP L/XL 8HR HEAT WRAP TO HIS LOWER BACK. ON (B)(6) 2022, AFTER USING THE PRODUCT, THE CONSUMER TOOK A SHOWER AND FELT A BURNING SENSATION FROM A DIME SIZE AREA ON HIS LOWER BACK. THE AREA LOOKED LIKE A BURN. THE HEAT WRAP WAS INTACT AND WITHOUT ANY TEARS. ON (B)(6) 2022, THE CONSUMER CALLED A DOCTOR AND A NURSE ADVISED HIM TO APPLY ALOE VERA CREAM TO THE AFFECTED AREA. AS OF (B)(6) 2022, THE CONSUMER ANTICIPATED MAKING AN APPOINTMENT WITH HER PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699685 THERMACARE LOWER BACK & HIP 8HR L/XL 2CT HOT OR COLD DISPOSABLE PACK. IMD ANGELINI ThermaCare HeatWraps - Lower Back & Hip 00305733010037

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention