BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3193607 · Received June 21, 2013

    Report

    Report Number
    MW5030684
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    February 25, 2009
    Report Date
    June 21, 2013
    Manufacturer
    CONCEPTUS INC
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROLONGED BLEEDING, ABSENT PERIODS, CYST, PAINFUL STABBING PAINS, HAIR LOSS, HAIR GROWTH NOT ON MY HEAD. DIFFICULTY LOOSING WEIGHT, MOOD SWINGS HOT FLASHES. VERTIGO, INSOMNIA. ROUTE: ENDOCERVICAL. DATE OF USE: PRESENT STILL HAVE, (B)(6) 2009 - (B)(6) 2013. DIAGNOSIS OR REASON FOR USE: BIRTH CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283824 ESSURE ESSURE BIRTH CONTROL HHS CONCEPTUS INC REF ESS305 628434

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R