BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1202846 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05373
    Event Type
    Injury
    Date Received
    October 17, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE USED IS UNK, CONSEQUENTLY THE DEVICE MFG AND EXPIRATION DATES ARE UNK. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVAL WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT APPROX A WEEK POST HTA PROCEDURE, THE PT RETURNED COMPLAINING OF A BURN ON HER LABIA. THE PHYSICIAN EXAMINED THE PT AND OBSERVED A BURN, NOT QUITE THE SIZE OF A QUARTER. THE PHYSICIAN APPLIED SILVADENE CREAM. THE PT RETURNED 2 DAYS LATER, AT WHICH TIME THE PHYSICIAN DID A PELVIC EXAM AND OBSERVED TWO ADDITIONAL 2ND DEGREE BURNS ON THE VAGINAL WALL WHICH WERE CONSISTENT ON BOTH SIDES. IT WAS REPORTED THAT THE SKIN WAS HEALING AT THAT POINT, IT IS UNK IF ANY TREATMENT WAS GIVEN. THE PT WAS INFORMED BY THE PHYSICIAN THAT THE BURNS WILL HEAL IN TIME. IT IS UNK IF THERE WAS A LOSS OF FLUID DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WERE NO FLUID LOSS ALARMS ACTIVATED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC CORPORATION M006560201 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R