BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1324955 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-02872
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    May 25, 2007
    Report Date
    May 25, 2007
    Manufacturer
    NORTH AMERICAN STERILIZATION AND PACKAGING CO.
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS REPORTED FOR MINOR CERVICAL BURN. THE DEVICE IS NOT EXPECTED TO BE RETURNED BECAUSE OF REASONS NOT DISCLOSED BY THE USER FACILITY. THEREFORE A DEVICE EVALUATION COULD NOT BE PERFORMED; THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT CONDUCTED BECAUSE THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2007 THAT A HYDROTHERMABLATOR PROCEDURE SET WAS USED DURING A ENDOMETRIAL ABLATION PROCEDURE PERFORMED THE SAME DAY (FEMALE PATIENT; AGE AND WEIGHT ARE UNKNOWN). DURING THE ABLATION, A SMALL AMOUNT OF FLUID, PERHAPS A QUANTITY OF 5CC, SPILLED ONTO THE CERVIX AND BURNED THE CERVIX. THE PROCEDURE WAS COMPLETED AND THE PHYSICIAN ADMINISTERED BACITRACIN OINTMENT. IN THE PHYSICIAN'S OPINION, IT WAS JUST LIKE A LEEP PROCEDURE. TH SALES REP SPOKE TO THE PHYSICIAN FOUR HOURS AFTER THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE PATIENT WAS FINE, "DOING GREAT," AND HAD NO DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB MNB NORTH AMERICAN STERILIZATION AND PACKAGING CO. M006560201 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other