BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP 8HR L/XL

    MDR report key: 15896528 · Received December 1, 2022

    Report

    Report Number
    3007593958-2022-00079
    Event Type
    Injury
    Date Received
    December 1, 2022
    Date of Event
    November 12, 2022
    Report Date
    November 29, 2022
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010396
    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 WAS LIMITED DEVICE-SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL ASSESSMENT CAN NOT 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 BURNS. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES, INCLUDING PROCESS TESTING, THERMAL TESTING, AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PACKAGED PRODUCT

    Description of Event or Problem · 0

    ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES VIA EMAIL REGARDING A FEMALE CONSUMER WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. MEDICAL HISTORY INCLUDED TYPE II DIABETES, UNSPECIFIED HEART PROBLEM(S), AND AN UNSPECIFIED THYROID DISORDER. THE CONSUMER HAD NO KNOWN DRUG ALLERGIES. CONCOMITANT PRODUCTS INCLUDED UNSPECIFIED ORAL MEDICATIONS FOR DIABETES, A HEART PROBLEM, AND HER THYROID CONDITION. ON (B)(6) 2022, THE CONSUMER'S DAUGHTER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP TO HER BACK. ON (B)(6) 2022, (B)(6) 2022, AND (B)(6) 2022 ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. ON (B)(6) 2022, APPROXIMATELY ONE HOUR AFTER USING A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP SHE FELT LIKE HER BACK WAS BURNING. THE CONSUMER'S DAUGHTER REMOVED THE WRAP BUT DID NOT LOOK AT THE SKIN. THE CONSUMER CONTINUED TO COMPLAIN THAT SHE EXPERIENCED PAIN AT THE APPLICATION SITE. ON THE EVENING OF (B)(6) 2022, HER DAUGHTER LOOKED AT THE SITE. SHE NOTED SEVERAL AREAS OF REDNESS THAT WERE IN THE SHAPE OF THE HEAT DISCS. SHE ALSO HAD TWO INTACT BLISTERS. ONE BLISTER WAS THE SIZE OF A PENNY AND THE OTHER ONE WAS SLIGHTLY SMALLER. HER BACK WAS BURNED. FOR TREATMENT, THE DAUGHTER APPLIED AN UNSPECIFIED BURN OINTMENT AND ALOE VERA GEL. FOR THE PAIN, SHE GAVE HER MOM TYLENOL (ACETAMINOPHEN). THE CONSUMER'S RELATIVE WAS WATCHING THE AREA OF CONCERN. AS OF (B)(6) 2022, THE CONSUMER HAD NOT BEEN EVALUATED BY A HEALTHCARE PROFESSIONAL. HER DAUGHTER WANTED TO TAKE HER TO AN EMERGENCY ROOM (ER), BUT THE CONSUMER REFUSED AS HER PAIN RESOLVED AND THE CONSUMER DID NOT FEEL THERE WAS A NEED TO GO TO THE ER. AS OF (B)(6) 2022, ALL OTHER SYMPTOMS WERE ONGOING. IT WAS CLARIFIED THAT THE HEAT WRAP WAS APPLIED AGAINST THE SKIN AS SHE DID NOT USE A LAYER OF CLOTHING IN BETWEEN THE HEAT WRAP AND THE SKIN. ON (B)(6) 2022, THE CONSUMER ADMITTED THAT SHE DID NOT READ ALL OF THE INFORMATION PROVIDED WITH THE PRODUCT, SINCE THERE WAS A PICTURE OF SOMEONE ON THE BOX WEARING IT APPLIED DIRECTLY TO THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2770219 THERMACARE LOWER BACK & HIP 8HR L/XL HOT OR COLD DISPOSABLE PACK. IMD ANGELINI GA0378 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention UNSPECIFIED MEDICATION FOR DIABETES.| UNSPECIFIED MEDICATION FOR THE HEART.| UNSPECIFIED MEDICATION FOR THE THYROID.