BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTOGEL HYPOTHERMIA MITTS & SLIPPERS

    MDR report key: 7992427 · Received October 22, 2018

    Report

    Report Number
    1929833-2018-00001
    Event Type
    Injury
    Date Received
    October 22, 2018
    Report Date
    October 19, 2018
    Manufacturer
    SOUTHWEST TECHNOLOGIES INC.
    Product Code
    IME
    Adverse Event
    Yes
    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, THE PATIENT SENT AN EMAIL TO SOUTHWEST TECHNOLOGIES EXPLAINING ABOUT 2 WEEKS PRIOR SHE USED THE SLIPPER AND MITT COOLING GEL PRODUCTS ON HER HANDS AND FEET DURING CHEMOTHERAPY AND SUFFERED SEVERE FROSTBITE ON HER FINGERS AND TOES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833354 ELASTOGEL HYPOTHERMIA MITTS & SLIPPERS PACK, HOT OR COLD, REUSABLE IME SOUTHWEST TECHNOLOGIES INC. TM7008, SL3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other