BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD TRANSURETHRAL INJECTION SYSTEM

    MDR report key: 1014073 · Received March 14, 2008

    Report

    Report Number
    1018233-2008-00013
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 13, 2008
    Report Date
    March 14, 2008
    Manufacturer
    C. R. BARD, INC.
    Product Code
    LNM
    PMA / PMN Number
    P900030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED COMPONENT LOT NUMBER FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE NEEDLE BEING USED WAS NOT ONE OF THOSE SPECIFIED FOR USE WITH THIS BULKING IMPLANT. THE RAW MATERIALS USED IN THE IMPLANT ARE KNOWN TO CAUSE DEGRADATION TO NEEDLES COMPRISED OF POLYURETHANE (SUCH AS THE ONE USED IN THIS PROCEDURE).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URETHRAL BULKING IMPLANT PROCEDURE IN 2008, USING AN OFF-LABEL BULKING IMPLANT MATERIAL, THE NEEDLE BROKE. THE DOCTOR USED THREE ADDITIONAL NEEDLES ATTEMPTING TO INJECT THE IMPLANT MATERIAL. ALL OF THE NEEDLES BROKE WHEN BEING USED WITH AN OFF-LABEL BULKING IMPLANT MATERIAL. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD TRANSURETHRAL INJECTION SYSTEM LNM C. R. BARD, INC. NA CVRL0040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK