BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESS305

    MDR report key: 3020851 · Received March 19, 2013

    Report

    Report Number
    MW5029466
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    May 9, 2012
    Report Date
    March 19, 2013
    Manufacturer
    CONCEPTUS INC, USA
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ESSURE PROCEDURE DONE, MULTIPLE ADVERSE REACTIONS. WEIGHT GAIN, NICKEL ALLERGY, PELVIC PAIN, BLEEDING, PAIN DURING INTERCOURSE WITH BLEEDING, DIZZY, BOWEL ISSUES, HAIR LOSS, HEADACHES, NIGHT SWEATS, SYNCOPAL EPISODES, AND MORE. I AM HAVING A PARTIAL HYSTERECTOMY ON (B)(6) 2013 TO HAVE THEM REMOVED DUE TO ALL OF THE ADVERSE REACTIONS. THIS PRODUCT SHOULD BE TAKEN OFF THE MARKET SO OTHER WOMEN DO NOT HAVE TO GO THROUGH THE PROBLEMS THAT I HAVE HAD, AS WELL AS OTHER WOMEN. I HAVE BEEN OUT OF WORK SINCE (B)(6) 2012 DUE TO PASSING OUT AND DIZZY SPELLS. I HAVE BEEN WORKED UP WITH A CARDIOLOGIST AND NEUROLOGIST DUE TO THESE SYMPTOMS THAT STARTED SHORTLY AFTER HAVING THE ESSURE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114401 ESS305 ESSURE HHS CONCEPTUS INC, USA 922602

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other