BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12934628 · Received December 6, 2021

    Report

    Report Number
    3007593958-2021-00045
    Event Type
    Injury
    Date Received
    December 6, 2021
    Report Date
    November 11, 2021
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010037
    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 WAS LIMITED DEVICE-SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER OR A RETURN SAMPLE, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THERE IS NOT A PRODUCT QUALITY-RELATED TREND IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE MANUFACTURING OPERATION EMPLOYS QUALITY CONTROL PROCEDURES, WHICH INCLUDE IN- PROCESS TESTING, THERMAL TESTING, AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PACKAGED PRODUCT. THIS IS AN ADVERSE EVENT FOR A BURN TO THE CONSUMERS' BACK. A RISK CALCULATION CANNOT BE DETERMINED AS THERE IS NO REASONABLE SUGGESTION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING A FEMALE (AGE NOT REPORTED) WHO USED THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS. MEDICAL HISTORY INCLUDED BACKPAIN. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP (LOT NUMBER NOT PROVIDED; EXPIRATION DATE (B)(6) 2023) APPLIED TOPICALLY TO THE BACK FOR BACK PAIN. AFTER THE CONSUMER HAD THE HEAT WRAP ON FOR 2 HOURS IT "BURN'T THE HELL OUT" OF THE CONSUMER'S BACK. FOLLOW-UP ATTEMPTS HAVE BEEN UNSUCCESSFUL. AS OF (B)(6) 2021, NO NEW ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830643 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 Female Required Intervention