BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 2193627 · Received July 13, 2011

    Report

    Report Number
    2951250-2011-00037
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    March 24, 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
    ID, 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

    PATIENT PRESENTED WITH LOCALIZED, LEFT SIDED PAIN POST-ESSURE PLACEMENT. THE PHYSICIAN PRESCRIBED PAIN MEDICATION BUT THE PAIN PERSISTED. THE PHYSICIAN PERFORMED HYSTEROSCOPY AND REMOVED WHAT HE BELIEVED TO BE PART OF THE DELIVERY CATHETER FROM THE LEFT SIDE TUBE. THE PATIENT IS FINE AND THE PHYSICIAN IS SCHEDULING AN ADDITIONAL HSG IN ONE MONTH'S TIME TO CONFIRM OCCLUSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention