BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7897660 · Received September 20, 2018

    Report

    Report Number
    MW5080036
    Event Type
    Injury
    Date Received
    September 20, 2018
    Date of Event
    August 5, 2018
    Report Date
    September 19, 2018
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN HAVING PELVIC PAIN ON MY LEFT SIDE FOR ABOUT 6 MONTHS. I FINALLY WENT TO MY PCP WHO ORDERED AN XRAY AND A CT CAN. MY ESSURE COIL ON MY LEFT THAT WAS PLACED ON (B)(6) 2018 HAD FRAGMENTED AND COME COMPLETE APART. MY DR FEELS THIS WHAT MY PAIN ALONG WITH HEAVY PERIODS WITH CLOTS ARE CAUSED BY. I HAVE ALSO BEEN EXPERIENCING HORRENDOUS MIGRAINES, PAINFUL SEX (NOT ABLE TO WITH HUSBAND IN AROUND 8 MONTHS) HAIR LOSS AND STOMACH PAIN AS WELL AS INSOMNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734385 ESSURE TRANSCERVICAL CONTRACEPTIVE HHS BAYER HEALTHCARE, LLC D23617

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization