BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIPRO II

    MDR report key: 3231290 · Received July 11, 2013

    Report

    Report Number
    MW5030889
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 6, 2013
    Report Date
    July 11, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUTURE NEEDLE BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320781 SURGIPRO II SUTURE NEEDLE GAM COVIDIEN D2G0571X

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other