BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONE STAR

    MDR report key: 1726953 · Received June 14, 2010

    Report

    Report Number
    MW5016383
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 14, 2010
    Manufacturer
    COOPER SURGICAL
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LONE STAR ELASTIC STAYS KEPT BREAKING AS SURGEON WAS APPLYING RETRACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONE STAR ELASTIC STAYS GDG COOPER SURGICAL 88511

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR