BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11872780 · Received May 24, 2021

    Report

    Report Number
    3007593958-2021-00017
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    April 29, 2021
    Report Date
    May 24, 2021
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE CAN NOT 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 BURNED HER AND THERE WAS REDNESS". THE CAUSE OF THE CONSUMER RECEIVING BURNS AND REDNESS IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID THE RISKS OF BURNS OR OTHER SKIN IRRITATIONS. THIS IS AN ADVERSE EVENT FOR A BURN AND A RISK CALCULATION CANNOT BE DETERMINED AS THERE IS NO REASONABLE SUGGESTION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING A FEMALE CONSUMER WHO USED THERMACARE LOWER BACK AND HIP L/XL 8HR 2CT. MEDICAL HISTORY INCLUDED BACK PAIN. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON THE NIGHT OF (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED THE THERMACARE LOWER BACK AND HIP L/XL 8HR 2CT. ON AN UNSPECIFIED AMOUNT OF TIME AFTER APPLYING THE PRODUCT, THE CONSUMER REMOVED THE WRAP. SHE NOTED HER SKIN WAS BURNED AND SHE HAD BLISTERS. THE CONSUMER MENTIONED SHE CONTACTED HER LAWYER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768379 THERMACARE LOWER BACK & HIP 8HR L/XL 2CT HOT OR COLD DISPOSABLE PACK. IMD ANGELINI ThermaCare HeatWraps - Lower Back & Hip EC7090 00305733010037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention