BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2903687 · Received January 7, 2013

    Report

    Report Number
    MW5028446
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SINCE SHE HAD THE ESSURE IMPLANTED IN HER, SHE HAS BEEN EXPERIENCING EXCRUCIATING PAIN IN HER OVARIES, LEG AND BACK. SHE SUFFERS FROM SIGNIFICANT SWELLINGS AND BLOATING IN HER ABDOMEN WHICH MAKES HER LOOK LIKE A PREGNANT LADY. AFTER CONSULTING WITH HER DOCTOR, HE INFORMED HER THAT HER UTERUS IS SEVERELY INFLAMED AND THAT SHE WILL NEED TO HAVE A HYSTERECTOMY. SHE ALSO REPORTED, SHE SUFFERS FROM IRREGULAR AND HEAVY MENSTRUAL PERIODS AND ALSO PAINFUL SEXUAL INTERCOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6228 ESSURE ESSURE HHS CONCEPTUS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1