BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLON 2001

    MDR report key: 325579 · Received April 2, 2001

    Report

    Report Number
    9616800-2001-00001
    Event Type
    Other
    Date Received
    April 2, 2001
    Date of Event
    March 17, 2001
    Report Date
    March 29, 2001
    Manufacturer
    MTRE ADVANCED TECHNOLOGY LTD.
    Product Code
    DWJ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT'S OPERATIVE COURSE WAS UNEVENTFUL. PT WAS TRANSPORTED TO ICU WITHOUT DIFFICULTY. PT WAS NORMOTHERMIC ON ARRIVAL TO ICU (36.8 DEGREES CELSIUS). WHILE IN THE ICU THERE WAS A DISCREPANCY BETWEEN PTS BLADDER CORE TEMPERATURE READINGS, WHICH WERE FLUCTUATING BETWEEN 36.8 AND 37.4 DEGREES CELSIUS AND THE CORE TEMPERATURE BEIND READ ON THE PULMONARY ARTERY CATHETER, WHICH WAS 37.6 DEGREES CELSIUS. THE ICU NURSING STAFF NOTED WHEN TURNING TO WASH THE PT THE NEXT DAY THERE WERE SYMMETRICAL, BOX-LIKE REDDENED AND RAW AREAS ON THE UPPER BACK (T5-T7 REGION, RIGHT SIDE WORSE THAN THE LEFT). THE NURSING STAFF INITIALLY THOUGHT THIS WAS RE-CTIVATION OF SHINGLES AND AN INFECTIOUS DISEASE CONSULT WAS OBTAINED, THEY RULED OUT SHINGLES, BUT RULED IN PRESSURE RELATED BURNS FROM THE THERMOREGULATION GARMENT. THEIR RECOMMENDATION WAS FOR LOCAL CARE AND SILVADENE CREAM TO THE AFFECTED AREA. OTHERWISE THE PT IS STABLE AND RECOVERING FROM SURGERY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14447 ALLON 2001 THERMAL REGULATING SYSTEM DWJ MTRE ADVANCED TECHNOLOGY LTD. 3365 (GARMENT) M008522 (GARMENT)

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other