BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP 8HR L/XL

    MDR report key: 15439866 · Received September 16, 2022

    Report

    Report Number
    3007593958-2022-00057
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    August 28, 2022
    Report Date
    September 15, 2022
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010037
    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 (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING A 65-YEAR-OLD MALE WHO USED A THERMACARE LOWER BACK AND HIP 8 HR L/XL HEAT WRAP. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON APPROXIMATELY (B)(6) 2022, THE CONSUMER APPLIED THE THERMACARE LOWER BACK AND HIP 8 HR L/XL HEAT WRAP TO HIS STOMACH AND THEN WENT TO BED AND FELL ASLEEP WHILE WEARING THE HEAT WRAP. APPROXIMATELY 8 TO 10 HOURS AFTER SLEEPING WHILE WEARING THE HEAT WRAP, HE WOKE UP ON HIS SIDE AND THE SKIN AT THE APPLICATION SITE WAS RED. THE SIDE OF HIS STOMACH THAT HE SLEPT ON WAS COVERED WITH BLISTERS. THE CONSUMER'S FRIEND ADVISED THE CONSUMER NOT TO WEAR THE PRODUCT DIRECTLY WHILE SLEEPING, BUT HE DID ANYWAY. IT WAS A BURN. THE BLISTERS WERE NOT OPEN, AND THEY WERE NOT GETTING WORSE. FOR TREATMENT, THE CONSUMER HAD BEEN APPLYING AN ANTIBIOTIC OINTMENT TO THE AREA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466404 THERMACARE LOWER BACK & HIP 8HR L/XL HOT OR COLD DISPOSABLE PACK. IMD ANGELINI ThermaCare HeatWraps - Lower Back & Hip 00305733010037

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention