BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4960070 · Received August 3, 2015

    Report

    Report Number
    MW5044964
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    December 29, 2014
    Report Date
    June 29, 2015
    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 HAD CHRONIC PELVIC AND LOWER BACK PAIN THAT DID NOT END. AS WELL AS CONSTANT VAGINAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504016 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 41.000 YR Hospitalization| O CITALOPRAM, FIORCET, FLEXORIL, TOPIRIMATE