BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 3212317 · Received July 8, 2013

    Report

    Report Number
    3212317
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 8, 2013
    Manufacturer
    CONCEPTUS, INC
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A HYSTEROSCOPY WITH PERMANENT STERILIZATION. ESSURE DEVICE WAS DEPLOYED PRIOR TO ACTIVATION; MINOR DELAY TO CASE RELATED TO OPENING ANOTHER DEVICE; NO HARM TO PATIENT- NOT USED.======================MANUFACTURER RESPONSE FOR ESSURE, ESSURE (PER SITE REPORTER).======================UNKNOWN AT THIS TIME; DEVICE RETURNED TO REP- UNSURE OF DATE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HYSTEROSCOPY WITH PERMANENT STERILIZATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311659 ESSURE DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE HHS CONCEPTUS, INC * 50718077

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR