BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 1902944 · Received November 12, 2010

    Report

    Report Number
    MW5018227
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 12, 2010
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN ESSURE TUBAL AND I AM NOW PREGNANT AND I AM ALSO WORRIED ABOUT THE COILS HARMING MY UNBORN CHILD OR PLACENTA AT ANY POINT. DIAGNOSIS OR REASON FOR USE: PERMANENT BIRTH CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE NONE HHS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other