BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2167096 · Received July 13, 2011

    Report

    Report Number
    2951250-2011-00040
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    March 21, 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
    FL, 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

    PT PRESENTED WITH PELVIC PAIN WITHIN DAYS OF ESSURE PLACEMENT. C-SECTIONS AND MESH, PT WAS REFERRED FOR REMOVAL. DEVICES WERE REMOVED LAPAROSCOPICALLY. AFTER REMOVAL, THE PT'S SYMPTOMS RESOLVED.

    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