BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2190628 · Received July 22, 2011

    Report

    Report Number
    2951250-2011-00045
    Event Type
    Injury
    Date Received
    July 22, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMENTS: THE AUTHOR/PHYSICIAN HAS NOT IMPLIED THAT THE ESSURE MICRO-INSERT IS THE SOURCE OF THE INFECTION, BUT DOES SUGGEST THAT THE DEVICE MAY SERVE AS A 'NIDUS' FOR INFECTION. CONCEPTUS HAS MADE THE CONSERVATIVE DECISION TO REPORT THIS EVENT ON THIS MDR, EVEN THOUGH NO DIRECT LINK BETWEEN THE DEVICES AND THE INFECTION HAVE BEEN MADE.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    INITIAL INFORMATION PROVIDED TO CONCEPTUS THROUGH JOURNAL OF WOMEN'S HEALTH, VOLUME 20, NUMBER 5, 2011. PATIENT PRESENTED WITH ACUTE ONSET OF LOWER QUADRANT ABDOMINAL PAIN 3 YEARS POST-ESSURE PLACEMENT. PATIENT DEMONSTRATED SIGNS OF ACUTE PERITONITIS SO EXPLORATORY LAPAROSCOPY WAS PERFORMED AND REVEALED RUPTURED TUBO-OVARIAN ABSCESS. ANTIBIOTICS INITIATED. POST-OP DAY 7, PATIENT HAD RECURRENCE OF ACUTE PERITONITIS NECESSITATING EVENTUAL HYSTERECTOMY. THE INFECTIOUS DISEASE CONSULTANT SUGGESTED REMOVAL OF ALL FOREIGN BODIES, INCLUDING MICRO-INSERTS, FROM PELVIS. HYSTERECTOMY WAS PERFORMED AND MICRO-INSERTS FOUND TO BE PROPERLY PLACED IN BOTH FALLOPIAN TUBES.

    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