BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYRUS DUAL FALLOPIAN RING APPLICATOR

    MDR report key: 1736515 · Received June 22, 2010

    Report

    Report Number
    MW5016475
    Event Type
    Injury
    Date Received
    June 22, 2010
    Date of Event
    May 19, 2010
    Report Date
    May 28, 2010
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    KNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT APPLIED TO FALLOPIAN TUBE TO APPLY RING FOR TUBAL LIGATION, LOADED INSTRUMENT MISFIRED AND RIPPED TUBE REQUIRING PROCEDURE TO BE COMPLETED BY FULGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYRUS DUAL FALLOPIAN RING APPLICATOR RING APPLICATOR KNH GYRUS MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other