BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1324956 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-02873
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    May 25, 2007
    Report Date
    May 29, 2007
    Manufacturer
    NORTH AMERICAN STERILIZATION AND PACKAGING CO.
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE ALARM THAT SOUNDED ALLOWED THE DOCTOR TO CONTINUE, ONE CAN ASSUME THAT IT WAS A FLUID LOSS ALARM. REPORTED COMPLAINT FOR THIS FLUID LOSS DEVICE IS NOT EXPECTED TO BE RETURNED, BECAUSE IT HAS ALREADY BEEN DISPOSED OF BY THE USER, THEREFORE, NO PRODUCT ANALYSIS COULD BE PERFORMED, AND NO ROOT CAUSE COULD BE DETERMINED. NO DHR REVIEW COULD BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 29, 2007 THAT A HYDROTHERMABLATOR PROCEDURE SET WAS USED DURING A ENDOMETRIAL ABLATION PROCEDURE PERFORMED IN 2007. (FEMALE PATIENT; AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, 8 MINUTES INTO THE ABLATION CYCLE, THE MACHINE ALARMED. THE PHYSICIAN CONTINUED THE PROCEDURE AND RECEIVED A SECOND ALARM. SHORTLY AFTER, HE ABORTED THE PROCEDURE AND THE PATIENT CALLED TODAY WITH ABDOMINAL BLOATING. THE PATIENT'S CONDITION IS REPORTED AS STABLE.

    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