BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3427238 · Received October 21, 2013

    Report

    Report Number
    MW5032362
    Event Type
    Injury
    Date Received
    October 21, 2013
    Date of Event
    August 1, 2006
    Report Date
    October 20, 2013
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD THE ESSURE PROCEDURE DONE, HAVE HAD CONSTANT LRQ PAIN AND PRESSURE, LOWER BACK PAIN, BLADDER ISSUES INCLUDING INCONTINENCE AS WELL AS BOWEL PROBLEMS, MIGRAINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537922 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other