BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 1924856 · Received December 8, 2010

    Report

    Report Number
    2951250-2010-00065
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    September 28, 2010
    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
    IL, 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

    A PHYSICIAN REPORTED THAT HIS PT WAS EXPERIENCING INTERMITTENT PELVIC PAIN FOLLOWING AN ESSURE MICRO-INSERT PLACEMENT PROCEDURE. THE PHYSICIAN STATED HE TRIED VARIOUS PAIN MEDICATIONS WITH NO RESOLUTION OF SYMPTOMS. A HSG REVEALED THAT THERE WAS A MICRO-INSERT IN THE LEFT TUBE BUT NO INSERT IN RIGHT TUBE; PT CONTINUED TO REPORT PAIN PROBLEMS. A FULL HYSTERECTOMY WAS PERFORMED AND THE ESSURE MICRO-INSERTS WERE REMOVED. POST-OP EXAMINATION OF THE TISSUE REMOVED FROM THE PT WAS PERFORMED AND BOTH MICRO-INSERTS WERE FOUND IN THE FALLOPIAN TUBES WITH PROPER PLACEMENT; NO PERFORATION WAS OBSERVED. THE PT'S PAIN RESOLVED FOLLOWING HYSTERECTOMY AND MICRO-INSERT REMOVAL.

    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