BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2050762 · Received March 31, 2011

    Report

    Report Number
    2951250-2011-00019
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    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 PHYSICIAN REPORTED MICRO-INSERT PLACEMENT PROCEDURE OCCURRED ON (B)(6) 2010. THE 3 MONTH POST PLACEMENT HSG REVIEW REFLECTED 3 TRAILING COILS ON LEFT SIDE AND 1 TRAILING COIL ON RIGHT. PET FIBERS IN PLACE BUT MICRO INSERT MIGRATED AND EMBEDDED INTO THE MYOMETRIUM LINING. LAPAROSCOPIC REMOVAL OF RIGHT TUBE (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 761440

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention