BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISIS DAVINCI BALLOON PORT

    MDR report key: 2021379 · Received February 8, 2011

    Report

    Report Number
    3003898360-2011-00034
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    November 8, 2010
    Report Date
    January 17, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR FOR EVAL, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: PIECE OF THE TIP OF DEVICE BROKE OFF INTO A PT DURING A GYN PROCEDURE. TIP WAS RETRIEVED. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISIS DAVINCI BALLOON PORT BALLOON PORT GCJ TELEFLEX MEDICAL NA 01G0900079

    Patients

    Seq Age Sex Outcome Treatment
    1