BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2269312 · Received September 26, 2011

    Report

    Report Number
    2951250-2011-00048
    Event Type
    Injury
    Date Received
    September 26, 2011
    Date of Event
    August 2, 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
    MN, 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

    REPORT OF PAIN, POST-ESSURE PLACEMENT. THE DEVICES WERE REMOVED LAPAROSCOPICALLY ON (B)(6) 2011. ON (B)(4) 2011, THE PHYSICIAN'S OFFICE REPORTS THAT THE PAIN HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 771092

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention