BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3161620 · Received June 4, 2013

    Report

    Report Number
    MW5030476
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    February 27, 2013
    Report Date
    June 4, 2013
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD ESSURE PROCEDURE DONE (B)(6) 2012. HSG TEST (B)(6) 2012. TEST SHOWED COIL IN RIGHT DISLODGED AND PUNCHED THROUGH FALLOPIAN TUBE ON RIGHT SIDE. HAD SURGERY TO CLAMP RIGHT TUBE BUT DOCTOR HAD TO REMOVE RIGHT TUBE BECAUSE THE COIL HAD PUNCHED THROUGH THE TUBE AND BEGAN TO WRAP AROUND MY TUBE. CURRENTLY WITH ANOTHER DOCTOR DUE TO LEFT SIDE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247154 ESSURE ESSURE HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R