BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 1914225 · Received November 18, 2010

    Report

    Report Number
    2951250-2010-00058
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 19, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PT PRESENTED TO HER PHYSICIAN WITH PELVIC PAIN 1 YEAR POST ESSURE PLACEMENT PROCEDURE. THE PHYSICIAN PERFORMED A BILATERAL SALPINGECTOMY AND REMOVED THE ESSURE MICRO-INSERTS. THE PHYSICIAN REPORTED THAT THE DEVICES APPEARED TO BE IN THE PROPER LOCATION AND WERE INTACT. THE PHYSICIAN ATTRIBUTED THE PT'S PAIN TO THE ESSURE MICRO-INSERTS. THE PHYSICIAN HAS NOT HAD F/U WITH PT SO IT IS UNK IF THE PT'S PAIN 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