BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROPLASTY RIGID ENDOSCOPIC NEEDLE 3.8FR X 14.5", 20GAX0.54"

    MDR report key: 3174652 · Received June 12, 2013

    Report

    Report Number
    MW5030546
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    UROPLASTY, INC
    Product Code
    LNM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC LOR-LOCK CONNECTOR END OF THE UROPLASTY ENDOSCOPIC NEEDLE BROKE OFF DURING USE. DIAGNOSIS OR REASON FOR USE: PERIURETHRAL INJECTION OF MACROPLASTIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266163 UROPLASTY RIGID ENDOSCOPIC NEEDLE 3.8FR X 14.5", 20GAX0.54" PERIURETHRAL INJECTION NEEDLE LNM UROPLASTY, INC MRN-420 27213

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR