BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3113596 · Received May 9, 2013

    Report

    Report Number
    2951250-2013-00009
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 22, 2013
    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
    VA, 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 HAD THE ESSURE PROCEDURE IN (B)(6) 2012. DURING THE PROCEDURE, THE PHYSICIAN USED THREE ESSURE DEVICES TO ACHIEVE PLACEMENT. IN (B)(6) 2013, PHYSICIAN PERFORMED AN HSG REVIEW TO CONFIRM LOCATION OF THE DEVICES. HSG SHOWED CORRECT POSITION OF THE DEVICES IN THE RIGHT AND LEFT FALLOPIAN TUBE. PHYSICIAN ALSO LOCATED THE THIRD DEVICE IN PT'S ABDOMINAL AREA. ON (B)(6) 2013, THE PHYSICIAN REMOVED THE THIRD DEVICE FROM THE ABDOMINAL AREA. DURING THE PROCEDURE, THE PHYSICIAN ALSO REMOVED THE RIGHT FALLOPIAN TUBE AND RIGHT DEVICE DUE TO A PERFORATION. PHYSICIAN ALSO NOTED AT TIME OF REMOVAL, THE PT HAS A SMALL FIBROID NEAR THE AREA OF THE ESSURE DEVICE. PHYSICIAN STATES THE FIBROID MAY HAVE BEEN A CONTRIBUTING FACTOR CAUSING IRRITATION. AFTER SURGERY, PT'S PAIN HAS SUBSIDED AND IS BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204697 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention