BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 1962565 · Received November 24, 2010

    Report

    Report Number
    MW5018988
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 15, 2008
    Report Date
    November 24, 2010
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EVER SINCE I HAVE HAD ESSURE PLACED IN TUBES, I HAVE HAD PROBLEMS. I HAVE BEEN TO THE DOCTOR MANY TIMES FOR BLEEDING FOR LONG PERIODS OF TIME WHICH WAS OVER 30 DAYS, ALSO SEVERE STOMACH CRAMPING WITH SHARP SHOOTING PAIN WHICH STILL GOES ON EVERYDAY. I DID NOT EXPERIENCE ANY OF THIS BEFORE I HAD THEM INSERTED. THE PAIN IS IN MY LOWER ABDOMEN AND IT IS VERY SORE IF I PRESS DOWN ON MY ABDOMEN IN THAT AREA. IT GETS WORSE WITH SEXUAL INTERCOURSE. PLEASE DO SOMETHING ABOUT THIS PROCEDURE. I REALLY WISH I CAN AFFORD TO HAVE THEM REMOVED SO I CAN HAVE MY BODY BACK PAIN FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 ESSURE ESSURE HHS CONCEPTUS 621809

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| S