BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATORIE

    MDR report key: 4648808 · Received March 19, 2015

    Report

    Report Number
    9681424-2015-00003
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Date of Event
    March 2, 2015
    Report Date
    March 19, 2015
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CANADA ULC
    Product Code
    FEN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A URODYNAMICS PROCEDURE, WHEN THE RECTAL BALLOON CATHETER WAS REMOVED FROM THE PATIENT AT THE END OF THE PROCEDURE, THE BALLOON PART SEPARATED FROM THE CATHETER AND REMAINED IN THE PATIENT. PATIENT WAS SENT NEXT DOOR TO THE SURGERY CENTER SO A PHYSICIAN COULD REMOVE THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188895 LATORIE ABDOMINAL PRESSURE CATHETER 9F FEN LABORIE MEDICAL TECHNOLOGIES CANADA ULC RPC-9 CM14119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other