BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3060141 · Received April 15, 2013

    Report

    Report Number
    MW5029740
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    November 5, 2007
    Report Date
    April 15, 2013
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES SHORTLY AFTER GETTING ESSURE IMPLANTED IN (B)(6) 2007, SHE HAS BEEN EXPERIENCING A SERIES OF ISSUES. CALLER REPORTS HAVING AN ALLERGIC REACTION TO NICKEL IN THE DEVICE, SINUS HEADACHES, SKIN RASH, ACNE, DEBILITATING MENSTRUAL CRAMPS, BLOOD CLOTS THE SIZE OF A SILVER DOLLAR, WEIGHT GAIN, AND METAL ODOR. CALLER ALSO STATES POSSIBLE CORRELATION TO A FIBROID REMOVED IN HER RIGHT BREAST TWO YEARS AFTER ESSURE WAS IMPLANTED. CALLER IS NOW SCHEDULED FOR A HYSTERECTOMY IN (B)(6) TO REMOVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161034 ESSURE COILS HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR