BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA PROCEDURE SETS

    MDR report key: 2240749 · Received September 9, 2011

    Report

    Report Number
    3005099803-2011-03014
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    NORTH AMERICAN STERILIZATION &
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION PROSERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, AT APPROXIMATELY 5 MINUTES INTO THE GENESYS HTA PROCEDURE, THE PATIENT REPORTED THAT HER "BUTTOCKS WAS HOT". THE PHYSICIAN NOTICED THAT THE PROCEDURE SET TUBING WAS RESTING ON HER BUTTOCKS AND A SLIGHT RED MARK WAS NOTED. SILVADENE CREAM WAS APPLIED TO THE AREA AND THE CASE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESYS HTA PROCERVA PROCEDURE SETS DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB NORTH AMERICAN STERILIZATION & M006580211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other