BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2041202 · Received March 29, 2011

    Report

    Report Number
    2951250-2011-00015
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 24, 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
    WI, 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

    ON (B)(6) 2011, DOCTOR REPORTED THAT A PATIENT WHO UNDERWENT ESSURE PLACEMENT IN (B)(6) 2010, HAS HAD PERSISTENT AND INCREASING LT LOWER QUADRANT PAIN. HSG SHOWS SATISFACTORY LOCATED LEFT MICRO INSERT. NO RIGHT DEVICE WAS PLACED DUE TO INABILITY TO CANNULATE TUBE AND PATIENT'S HISTORY. THE HSG SHOWED THE TUBE WAS EITHER OCCLUDED OR ABSENT. HE HAS THE PATIENT SCHEDULED FOR ESSURE MICROINSERT REMOVAL SECONDARY TO PELVIC PAIN. ON (B)(4) 2011, DOCTOR REMOVED THE ESSURE MICRO INSERT (B)(6) 2011. WAS ABLE TO REMOVE BOTH THE INNER/OUTER COILS COMPLETELY, ALTHOUGH THEY WERE SEPARATED UPON REMOVAL (NO CLINICAL SIGNIFICANCE). HE SAID THERE WAS NO DIFFICULTY REMOVING THE MICRO INSERT AND IT DID APPEAR TO BE IN THE FALLOPIAN TUBE. HE DID NOTE THE PATIENT HAD A LARGE OVARIAN CYST ON THE CONTRALATERAL SIDE WHICH MAY HAVE CAUSED SOME OF THE PELVIC PAIN THE PATIENT WAS EXPERIENCING, ALTHOUGH HE DID FEEL THE MICRO INSERT WAS ALSO CONTRIBUTING TO HER PAIN. THE PATIENT IS DOING WELL, NO OTHER PROBLEMS AT THIS TIME.

    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