BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1943503 · Received December 1, 2010

    Report

    Report Number
    2951250-2010-00060
    Event Type
    Other
    Date Received
    December 1, 2010
    Date of Event
    October 22, 2010
    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
    TX, 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 PATIENTS WITH SUSPECTED HYPERSENSITIVITY TO NICKEL). IFU WARNING: PATIENTS WITH SUSPECTED HYPERSENSITIVITY TO NICKEL SHOULD UNDERGO A SKIN TEST TO ASSESS HYPERSENSITIVITY PRIOR TO AN ESSURE PLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT HER PT PRESENTED TO HER COMPLAINING OF SKIN IRRITATION AND WELTS OVER HER BODY FOLLOWING THE ESSURE MICRO-INSERT PLACEMENT PROCEDURE. A NICKEL ALLERGY TEST WAS PERFORMED ON THE PT AND THE PT WAS CONFIRMED POSITIVE FOR NICKEL ALLERGY. THE PHYSICIAN REMOVED THE ESSURE MICRO-INSERTS AND BELIEVED IT WAS NECESSARY DUE TO THE PATIENT'S NICKEL ALLERGY. PHYSICIAN IS NOT AVAILABLE FOR FOLLOW UP INQUIRIES, SO IT IS UNK AT THIS TIME IF THE PATIENT'S SYMPTOMS HAVE RESOLVED FOLLOWING ESSURE MICRO-INSERT 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