BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 2020315 · Received March 11, 2011

    Report

    Report Number
    2951250-2011-00012
    Event Type
    Other
    Date Received
    March 11, 2011
    Date of Event
    February 11, 2011
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IFU CONTRAINDICATION: THE ESSURE SYSTEM SHOULD NOT BE USED IN ANY PT WITH KNOWN HYPERSENSITIVITY TO NICKEL CONFIRMED BY SKIN TEST (SEE WARNINGS SECTION BELOW FOR PTS WITH SUSPECTED HYPERSENSITIVITY TO NICKEL). IFU WARING: PTS WITH SUSPECTED HYPERSENSITIVITY TO NICKEL SHOULD UNDERGO A SKIN TEST TO ASSESS HYPERSENSITIVITY PRIOR TO AN ESSURE PLACEMENT PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ESSURE IMPLANTED IN (B)(6) 2010. PT PRESENTED WITH ABDOMINAL PAIN AND ABNORMAL UTERINE BLEEDING SINCE THE TIME OF THE ESSURE PROCEDURE. THE PT REPORTS BLEEDING/SPOTTING DAILY. PT ALSO NOW REPORTING A HISTORY OF REACTIONS TO NICKEL JEWELRY. NO CONFIRMATORY HSG PERFORMED DUE TO LOSS OF INSURANCE. THE PHYSICIAN BELIEVES THAT THE PAIN AND ABNORMAL BLEEDING THAT THE PT IS COMPLAINING OF IS LIKELY DUE TO THE ESSURE DEVICE. THE PT IS BEING SCHEDULED FOR ALLERGY TESTING FOR CONFIRMATION OF POSSIBLE REACTIONS TO NICKEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention