BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 2213999 · Received June 22, 2011

    Report

    Report Number
    2951250-2011-00035
    Event Type
    Other
    Date Received
    June 22, 2011
    Date of Event
    April 29, 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
    AZ, 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 WARNING: 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

    POST ESSURE PLACEMENT REPORT OF NICKEL ALLERGY; PT IS EXPERIENCING MIGRAINE HEADACHES SINCE DEVICE PLACEMENT, ABOUT 2 YEARS. CURRENT PHYSICIAN IS NOT THE DOCTOR WHO PLACED THE DEVICES. THE PT HAS NOT HAD NICKEL ALLERGY PERFORMED, HOWEVER, THE PHYSICIAN FELT THE BEST SOLUTION WOULD BE TO REMOVE THE DEVICES. THE DEVICES WERE REMOVED BY LAPAROSCOPY WITHOUT DIFFICULTY. SYMPTOMS HAVE RESOLVED SINCE DEVICE REMOVAL.

    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 Required Intervention