BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 565123 · Received January 7, 2005

    Report

    Report Number
    MW1034278
    Event Type
    Other
    Date Received
    January 7, 2005
    Date of Event
    January 6, 2005
    Report Date
    January 7, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MNB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING HYDROTHERMABLATION PROCEDURE, IT WAS NOTED THAT 10 CC OF NORMAL SALINE WAS LOST. THE PT SUBSEQUENTLY RECEIVED BURNS TO THE INNER AND OUTER VAGINAL TISSUE AS WELL AS THE PERINEUM ADN BILATERAL GLUTEAL REGIONS. IT WAS NOTED DURING THE PROCEDURE THAT THE VAGINAL PACKING AND THE DILATOR WERE REMOVED PRIOR TO THE ABLATION END-TIME. IT WAS ALSO NOTED FOLLOWING THE CASE THAT THE HYDROTHERMABLATION EQUIPMENT WAS MALFUNCTIONING. THE EQUIPMENT WOULD NOT "COOL DOWN" AND WOULD NOT ALLOW THE MACHINE TO BE RESET OR TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC HYDRO-THERMABLATION UNIT MNB BOSTON SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other NONE NOTED.