BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 1841899 · Received September 17, 2010

    Report

    Report Number
    2951250-2010-00050
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 22, 2010
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    A PATIENT REPORTED AN ECTOPIC PREGNANCY 4 YEARS FOLLOWING THE ESSURE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS205 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention