BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FALOPE-RING BAND APPLICATION KIT

    MDR report key: 1654724 · Received April 5, 2010

    Report

    Report Number
    MW5015475
    Event Type
    Injury
    Date Received
    April 5, 2010
    Date of Event
    March 26, 2010
    Report Date
    April 5, 2010
    Manufacturer
    GYRUS ACMI INC
    Product Code
    KNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A BILATERAL TUBAL LIGATION PERFORMED. THE LEFT FALLOPIAN TUBE WAS SEVERED WHILE ATTEMPTING TO DEPLOY THE FALOPE RING BAND. SAME THING HAPPENED WITH THE RIGHT TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALOPE-RING BAND APPLICATION KIT FALOPE-RING BAND APPLICATION KIT KNH GYRUS ACMI INC 145670AC

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Disability