BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA

    MDR report key: 3010776 · Received March 13, 2013

    Report

    Report Number
    MW5029393
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MNB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE GENESYS DEVICE WAS INSERTED AND NORMAL SALINE INSTILLED ON A DISTENDING MEDIA. A MOIST GAUZE WAS PLACED IN THE VAGINA. THE THERAPY CYCLE STARTED AND 90 DEGREE TEMPERATURE OF FLUID OBTAINED. PT BEGAN TO BACK ON THE TABLE AND FLUID LOSS WAS NOTED, AND THE PROCEDURE WAS ABORTED. A NORMAL COOL-DOWN CYCLE WAS ACCOMPLISHED BUT PERINEAL BURNS WERE NOTED. THE GENESYS DEVICE WAS REMOVED AND THE GAUZE. TOPICAL SILVADENE CREAM AND ICE PACKS WERE APPLIED. THE PT WAS ADMITTED OVERNIGHT INSTEAD OF THE PLANNED DISCHARGE HOME AS A SAME DAY PROCEDURE. A FOLEY CATHETER WAS PLACED FOR COMFORT. PT WAS DISCHARGED THE NEXT DAY. BURN AREA ON DAY OF DISCHARGE WAS DOCUMENTED AS PARTIAL THICKNESS, REDDENED MOIST WITHOUT BLISTERING, EXTENDING FROM VAGINAL TO RECTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106236 GENESYS HTA GENESYS MNB BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O LOT # NA| GENESYS HTA PROCERVA PROCEDURE SET| CATALOG #58021, PRODUCT #M006580210