BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3193514 · Received June 20, 2013

    Report

    Report Number
    MW5030676
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    January 29, 2013
    Report Date
    June 20, 2013
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD ESSURE IMPLANTED ON (B)(6) 2013. RIGHT AWAY I HAD SEVERE CRAMPING AND TINGLING FROM EXTREMITIES. THE CRAMPING WAS MOSTLY ON MY LEFT SIDE AND SEVERE. IT LASTED UNTIL (B)(6) 2013 WHEN I HAD THE COILS REMOVED. REASON FOR USE: BIRTH CONTROL. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281784 ESSURE ESSURE HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization