BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC HYDROTHERMABLATOR

    MDR report key: 850427 · Received May 4, 2007

    Report

    Report Number
    MW1042835
    Event Type
    Other
    Date Received
    May 4, 2007
    Date of Event
    February 21, 2007
    Report Date
    April 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGICAL PROCEDURE: ENDOMETRIAL ABLATION OF THE UTERUS. AT CONCLUSION OF THE SURGERY, THE DRAPE WAS REMOVED FROM THE PT. IT WAS NOTED THAT THE PT RECEIVED A FIRST DEGREE BURN ON THE RIGHT THIGH DUE TO THE THERMAL ABLATION TUBING (CORD) BEING PLACED ON TOP OF THE THIGH DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC HYDROTHERMABLATOR HYDRO THERMAL ABLATION UNIT MNB BOSTON SCIENTIFIC CORP. 56000-M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other