BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLON 2001, THERMOWRAP

    MDR report key: 2713879 · Received August 22, 2012

    Report

    Report Number
    9616800-2011-00001
    Event Type
    Other
    Date Received
    August 22, 2012
    Date of Event
    March 8, 2011
    Report Date
    August 21, 2012
    Manufacturer
    MTRE ADVANCED TECHNOLOGY LTD.
    Product Code
    DWJ
    PMA / PMN Number
    K024128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORT WAS SUBMITTED BY MISTAKE ON 3500 FORM INSTEAD OF 3500A. NOW IS BEING REVISED FOLLOWING FDA REQUEST. THE ALLON AND THERMOWRAPS WERE USED ON (B)(6) PT DURING A SURGICAL PROCEDURE LASTING 7.5 HOURS. THE PT HAD RED MARKS ON HIS BODY FOLLOWING THE PROCEDURE WHICH LOOKED LIKE BURNS, TWO DAYS AFTERWARDS, THE MARKS DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLON 2001, THERMOWRAP THERMOREGULATION SYSTEM DWJ MTRE ADVANCED TECHNOLOGY LTD. ALLON 2001 THERMOWRAP M100471

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR