BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3050297 · Received April 8, 2013

    Report

    Report Number
    MW5029685
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 1, 2006
    Report Date
    April 8, 2013
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES HAVING ESSURE PLACED IN 2006 AFTER HAVING LAST CHILD. CALLER REPORTS THAT HER DOCTOR INSISTED ON ESSURE AS OPPOSED TO TUBAL LIGATION. AFTER INSERTION OF DEVICE CALLER REPORTS EXPERIENCING A RASH ALL OVER HER BODY FROM NICKEL, JOINT PAIN, FATIGUE, NAUSEA, DIZZINESS, HIP/LOWER BACK/PELVIC PAIN, PERFORATION OF FALLOPIAN TUBES, AND SCAR TISSUE. CALLER STATES IMMEDIATELY POST INSERTION SHE EXPERIENCED HEMORRHAGING FOR 3 MONTHS AND HAD TO GET AN ABLATION/CAUTERIZATION. CALLER STATES THAT SHE IS NOW FORCED TO GET A HYSTERECTOMY IN ORDER TO REMOVE THE COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144280 ESSURE COILS HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR