BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4905235 · Received July 10, 2015

    Report

    Report Number
    MW5043868
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    June 3, 2014
    Report Date
    June 8, 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). EQUIPMENT MALFUNCTIONED DURING INSERTION. DEVICE HAD TO BE CUT OFF OF THE EJECTOR. LATER HAD TO HAVE COILS REMOVED BY SURGERY AND NOW HAVE HAD 2 PERIOD CYCLES PER MONTH SINCE. THEY ARE ALSO VERY PAINFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450376 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 34.000 YR Hospitalization| R