BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAL-MAX HEAT PACK

    MDR report key: 15448673 · Received September 19, 2022

    Report

    Report Number
    3008412545-2022-00001
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    August 22, 2022
    Report Date
    August 19, 2022
    Manufacturer
    LIFE WEAR TECHNOLOGIES, INC.
    Product Code
    IME
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LIFE WEAR'S ABILITY TO INVESTIGATE THIS INCIDENT HAS BEEN LIMITED BY A LACK OF INFORMATION FROM THE PATIENT AND THE INABILITY TO INSPECT THE DEVICE THAT WAS INVOLVED IN THE INCIDENT. LIFE WEAR HAS CONDUCTED ADDITIONAL TESTING ON RETAINED DEVICES, INCLUDING REJECTED DEFECTIVE DEVICES THAT REPRESENT A "WORST CASE" SCENARIO, AND HAS BEEN UNABLE TO DUPLICATE THE REPORTED RESULT (I.E., RUPTURE OF THE DEVICE) WITHOUT SIGNIFICANTLY EXCEEDING THE HEATING INSTRUCTIONS STATED IN THE DEVICE LABELING. A REVIEW OF PRODUCTION RECORDS AND COMPLAINT FILES DOES NOT SUGGEST ANY TREND ASSOCIATED WITH THIS TYPE OF EVENT. LIFE WEAR HAS NOT RECEIVED ANY COMPLAINTS OF SIMILAR TYPES OF FAILURES OR INJURIES.

    Description of Event or Problem · 0

    PATIENT'S ATTORNEY STATED DEVICE "EXPLODED" IN MICROWAVE WHEN PATIENT RETRIEVED THE DEVICE. MADE A LOUD SOUND WHEN EXPLODING. HEATED LIQUID INSIDE DEVICE CONTACTED PATIENT, INCLUDING THROUGH CLOTHING, CAUSING 2ND DEGREE BURNS ON TORSO, HANDS, AND FACE. ATTORNEY DID NOT KNOW HOW LONG PATIENT HEATED THE DEVICE IN MICROWAVE. PATIENT HAS USED THE PRODUCT MULTIPLE TIMES BEFORE. ATTORNEY CONFIRMED THE HEATING PAD WAS IN THE COMFORT WRAP WHEN THE INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2827838 THERMAL-MAX HEAT PACK REUSABLE HOT PACK IME LIFE WEAR TECHNOLOGIES, INC. NONE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Required Intervention