BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4113480 · Received September 24, 2014

    Report

    Report Number
    MW5038263
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    March 10, 2008
    Report Date
    September 19, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). I WAS IMPLANTED WITH A MEDICAL DEVICE IMPLANT CALLED ESSURE IN 2007. THIS MEDICAL DEVICE IMPLANT IS NOW MANUFACTURED BY BAYER, FORMALLY BY CONCEPTUS INC. MY LOT NUMBER IS 624474. MY MODEL NUMBER IS ESS205. THIS DEVICE HAS A THREE YEAR SHELF LIFE; HOWEVER, I DO NOT HAVE THAT EXPIRATION DATE. CHRONIC FATIGUE, BROKEN BONES, VITAMIN D DEFICIENCY, SHINGLES, CURRENTLY A PUNCTURED UTERINE WALL, HEADACHES, BACTERIAL VAGINOSIS, YEAST INFECTIONS, UNCOMFORTABLE SEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593322 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 38.000 YR Hospitalization| O| S ESSURE, ZOLOFT