BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12811634 · Received November 15, 2021

    Report

    Report Number
    3007593958-2021-00043
    Event Type
    Injury
    Date Received
    November 15, 2021
    Date of Event
    September 27, 2021
    Report Date
    November 15, 2021
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE CANNOT 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 " BECAME TOO HOT". THE CAUSE OF THE CONSUMER STATING THE WRAP "BECAME TOO HOT" IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING A FEMALE (REPORTER DECLINED TO PROVIDE THE CONSUMER'S AGE; SHE WAS A SENIOR) WHO WAS USING THERMACARE LOWER BACK AND HIP 8HR L/XL. MEDICAL HISTORY INCLUDED PRIOR USE OF THERMACARE FOR YEARS AND "SEVERAL PAIN CONDITIONS." THE REPORTER REFUSED TO PROVIDE ADDITIONAL MEDICAL HISTORY OR INFORMATION REGARDING CONCOMITANT PRODUCTS. THREE WEEKS PRIOR TO (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED ONE THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP (LOT NUMBER: EK9242, EXPIRATION DATE: 31-OCT-2023) TO HER LOWER BACK DIRECTLY ON THE SKIN. WITHIN A FEW MINUTES, IT BECAME TOO HOT. SUBSEQUENTLY, SHE DOUBLED OVER A HAND TOWEL AND PUT IT BETWEEN THE WRAP AND HER SKIN. AFTER IT WAS ON FOR 15 MINUTES, IT AGAIN BECAME SO HOT THAT SHE WAS VERY UNCOMFORTABLE, AND SHE WANTED TO REMOVE IT. SHE ASKED A STRANGER TO REMOVE IT FOR HER IN A RESTROOM AND SHE PUT IT HER PURSE. HER DISCOMFORT RESOLVED SOON AS THE HEAT WRAP WAS OFF. THERE WAS NO FURTHER DISCOMFORT NOR INJURY. SHE WAS ASYMPTOMATIC. THE HEAT WRAP BECAME VERY HOT INSIDE HER PURSE. THE CONSUMER NOTED THAT THE HEAT WRAP MUST BE DEFECTIVE BECAUSE OF THIS. THE CONSUMER DID NOT WANT TO PROVIDE ANY FURTHER INFORMATION REGARDING HER HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715772 THERMACARE LOWER BACK & HIP 8HR L/XL 2CT HOT OR COLD DISPOSABLE PACK. IMD ANGELINI ThermaCare HeatWraps - Lower Back & Hip EK9242 00305733010037

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention