BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7768639 · Received August 8, 2018

    Report

    Report Number
    MW5078967
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    January 1, 2014
    Report Date
    August 6, 2018
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH ESSURE IN 2013, ABOUT 6 MONTHS AFTER I STARTED HAVING SOME UNEXPLAINED PAINS IN MY JOINTS. THIS HAS BEEN ON-GOING AND HAS SPREAD TO MY MUSCLES AS WELL. I HAVE BEEN IN CHRONIC PAIN SINCE, WORSENING AS THE YEARS GO BY. I ALSO HAVE CHRONIC MIGRAINES, PAINFUL AND LONG PERIODS, TROUBLE CONCENTRATING, MEMORY ISSUES, INFLAMMATION, AND WEIGHT GAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606587 ESSURE TRANSCERVICAL CONTRACEPTIVE HHS BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Disability