BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3896160 · Received June 20, 2014

    Report

    Report Number
    MW5036805
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    February 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD ESSURE INVERTED 2012 HAVE HAD 6 INPATIENT HOSPITALIZATIONS, ABDOMINAL PAIN, NAUSEA, VOMITING, INCREASED MENSTRUAL BLEEDING. DEVELOPED A RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363900 ESSURE ESSURE HHS CONCEPTUS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization