BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADIANA

    MDR report key: 2792374 · Received September 28, 2012

    Report

    Report Number
    2792374
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 24, 2011
    Report Date
    September 28, 2012
    Manufacturer
    HOLOGIC
    Product Code
    KNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE FAILED TO DEPLOY THE COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADIANA OCCLUSION, TUBAL, CONTRACEPTIVE KNH HOLOGIC * 11B15RB-105

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR