BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1324789 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-02450
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    October 19, 2007
    Report Date
    October 19, 2007
    Manufacturer
    NORTH AMERICAN STERILIZATION AND PACKAGING CO.
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE, AND THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT IN 2007 A HYDROTHERMABLATOR PROCEDURE SET WAS USED DURING A HYDROTHERMAL ABLATION PROCEDURE IN A FEMALE PATIENT (AGE & WEIGHT UNKNOWN) THE SAME DAY. ACCORDING TO THE COMPLAINANT, "DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT 4X4 GAUSSES WERE SATURATED WITH SALINE AND HOT AND BURNED THE CERVIX. THE HTA MACHINE DID NOT GIVE A FLUID LOSS ALARM AND THE NURSE IN THE ROOM CONFIRMS NO NOTICEABLE FLUID LOSS IN THE RESERVOIR." THE PATIENT SUFFERED A MINOR BURN ON THE CERVIX, WHICH WAS TREATED WITH SILVADENE CREAM. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A COMPETITOR'S PRODUCT (THERMACHOICE). THE PHYSICIAN REPORTED THE PATIENT IS DOING "FINE".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other