BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1061414 · Received June 17, 2008

    Report

    Report Number
    3005099803-2008-00733
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT EXPECTED TO BE BACK IN FACILITY FOR EVALUATION. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    DURING HYDROTHERABLATOR ABLATION PROCEDURE, THE UTERUS WAS PERFORATED WITH SOUND, EXPOSING THE BOWEL. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE CASE. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC CORPORATION M006550161 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other