BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3875289 · Received June 16, 2014

    Report

    Report Number
    MW5036609
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 17, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAVING SEVERE PELVIC PAINS. WAS TOLD ONE OF MY COILS IS MISSING. STILL IN PAIN. NO EXPLANATION OF THE PAIN OR ANYTHING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352850 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 26.000 YR Other ESSURE