BEUDAMED
    FDA Adverse Event Summary report: N

    MEDI-THERM III

    MDR report key: 1589456 · Received December 28, 2009

    Report

    Report Number
    1589456
    Date Received
    December 28, 2009
    Date of Event
    November 23, 2009
    Report Date
    December 28, 2009
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    DWJ
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    A MECHANICAL COOLING SYSTEM WAS USED TO TREAT THE PATIENT'S HIGH TEMPERATURE. SUBSEQUENTLY, DARK, REDDENED REGIONS, NON-BLANCHABLE TO BILATERAL ANTERIOR THIGHS AND LOWER ABDOMEN. REGIONS ARE NORMAL TEMPERATURE TO TOUCH. REGIONS ARE NOT INCREASING, SPREADING, OR CHANGING IN SHAPE, COLOR, OR TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-THERM III SYSTEM, THERMAL REGULATING DWJ GAYMAR INDUSTRIES, INC. MTA6900 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR