BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 2932113 · Received January 20, 2013

    Report

    Report Number
    MW5028700
    Event Type
    Malfunction
    Date Received
    January 20, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 20, 2013
    Manufacturer
    CONCEPTUS, INC
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD THE ESSURE COILS PLACED IN 2010 TO END THE CHANCE OF GETTING PREGNANT. FOUND OUT YESTERDAY THAT PRODUCT FAILED AND I AM 7 1/2 WEEKS PREGNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28596 ESSURE ESSURE COILS HHS CONCEPTUS, INC UNSURE

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other ESSURE