BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK AND HIP 8HR L/XL

    MDR report key: 14830252 · Received June 27, 2022

    Report

    Report Number
    3007593958-2022-00039
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    June 2, 2022
    Report Date
    June 24, 2022
    Manufacturer
    ANGELINI
    Product Code
    IMD
    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 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 72-YEAR-OLD MALE WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL. MEDICAL HISTORY INCLUDED HIGH BLOOD PRESSURE, USE OF THERMACARE WITHOUT ISSUE, AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. CONCOMITANT PRODUCTS INCLUDED AN UNSPECIFIED MEDICATION FOR BLOOD PRESSURE. APPROXIMATELY AT 6 AM TO 6:30 AM ON 02-JUN-2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HR L/XL TO HIS LOWER BACK ON TOP OF HIS CLOTHES. A FEW HOURS AFTER APPLYING THE PRODUCT, CLARIFIED AS BETWEEN 11:30 AM TO 12:00 PM, HE BEGAN TO EXPERIENCE PAIN AT THE APPLICATION SITE. SUBSEQUENTLY, HE REMOVED THE HEAT WRAP. HE NOTICED THAT HE HAD A BURN AT THE APPLICATION SITE. HE DID NOT APPLY THE PRODUCT AGAIN. FOR TREATMENT, HE APPLIED ALOE TO THE AREA. NO FURTHER MEDICAL TREATMENT WAS PURSUED. AS OF (B)(6) 2022, THE CONSUMER'S SYMPTOMS WERE IMPROVING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043448 THERMACARE LOWER BACK AND HIP 8HR L/XL HOT OR COLD DISPOSABLE PACK. IMD ANGELINI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention UNSPECIFIED BLOOD PRESSURE MEDICATION