BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY

    MDR report key: 3201082 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11852
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, AT APPROXIMATELY SEVEN MINUTES INTO THE THERAPY CYCLE, THERE WAS A LOW PRESSURE WARNING. UPON COMPLETION OF THE THERAPY, IT WAS NOTED THE CATHETER HAD A SMALL LEAK. THE PHYSICIAN STATED THAT 30CC OF FLUID HAD BEEN PUT INTO THE CATHETER AND GOT ONLY 20CC BACK. THE PROCEDURE WAS COMPLETED USING THE CATHETER WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301579 GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1