BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALOPE RING BAND

    MDR report key: 1487878 · Received September 22, 2009

    Report

    Report Number
    1487878
    Event Type
    Malfunction
    Date Received
    September 22, 2009
    Date of Event
    September 17, 2009
    Report Date
    September 22, 2009
    Manufacturer
    GYRUS ACMI MEDICAL, INC.
    Product Code
    KNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    ACMI GYRUS FALOPE-RING BAND MISFIRED -- CAUSED NO INJURY, BUT A SECOND KIT REQUIRED TO BE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALOPE RING BAND KIT, CONTRACEPTIVE, TUBAL OCCLUSION KNH GYRUS ACMI MEDICAL, INC. * 8191088

    Patients

    Seq Age Sex Outcome Treatment
    1 *