BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 4728360 · Received April 22, 2015

    Report

    Report Number
    MW5042261
    Event Type
    Other
    Date Received
    April 22, 2015
    Date of Event
    August 1, 2006
    Report Date
    April 22, 2015
    Manufacturer
    BAYER HEALTHCARE
    Product Code
    HHS
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS HAVING ESSURE IMPLANTED IN (B)(6) 2006. THE DEVICE WAS ONLY SUCCESSFULLY IMPLANTED ON ONE SIDE. TWO MONTHS LATER, CALLER HAD REVISION PROCEDURE WHEN THE ONE IMPLANTED WAS REMOVED AND A NEW ONE WAS INSERTED ALONG WITH THE SIDE THAT DID NOT HAVE DEVICE INITIALLY INSERTED. CALLER STATED THAT FOR THE LAST 2 YEARS SHE'S BEEN EXPERIENCING EXCRUCIATING PAIN CAUSED BY THE ESSURE. SHE IS NOT SEEKING A SECOND OPINION BY AN OBGYN SPECIALIST IN HOPES TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268030 ESSURE IUD HHS BAYER HEALTHCARE
    268194 ESSURE IUD HHS BAYER HEALTHCARE
    268195 ESSURE IUD HHS BAYER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR