BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTOGEL HYPOTHERMIA MITTS

    MDR report key: 7992583 · Received October 22, 2018

    Report

    Report Number
    1929833-2018-00002
    Event Type
    Injury
    Date Received
    October 22, 2018
    Report Date
    October 19, 2018
    Manufacturer
    SOUTHWEST TECHNOLOGIES, INC.
    Product Code
    IME
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION WAS GIVEN AS TO THE LOT NUMBER OF THE PRODUCT USED. THE LOT NUMBER REFERENCES THE PRODUCTION DATE OR A CLOSE PROXIMITY OF THE DATE OF PRODUCTION. THE PRODUCT USED DOES NOT CARRY AN EXPIRATION DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A PATIENT CALLED TO REPORT AN ADVERSE EVENT WHILE USING THE HYPOTHERMIA MITTS SHE PURCHASED ON (B)(6) 2017. SHE SAID SHE GOT FROSTBITE ON 3 FINGERS AND WILL BE LOSING ALL 3 FINGERS DUE TO FROSTBITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829470 ELASTOGEL HYPOTHERMIA MITTS PACK, HOT OR COLD, REUSABLE IME SOUTHWEST TECHNOLOGIES, INC. TM7008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other