BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1081898 · Received July 18, 2008

    Report

    Report Number
    2951250-2008-00015
    Event Type
    Other
    Date Received
    July 18, 2008
    Date of Event
    June 3, 2008
    Report Date
    February 14, 2017
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    ESSURE PROCEDURE DONE IN 2007; NO ABNORMAL EVENTS DURING PLACEMENT. HSG SHOWED PROPER PLACEMENT AND OCCLUSION. FOLLOWING THE HSG, PT BEGAN TO EXPERIENCE RIGHT SIDE PAIN WHICH INCREASED IN SEVERITY OVER TIME. PELVIC ULTRASOUND WAS PERFORMED WHICH SUGGESTED THAT THE RIGHT MICRO-INSERT WAS PERFORATED INTO THE MYOMETRIUM. PHYSICIAN NOTIFIED CONCEPTUS THAT THE PT OPTED FOR DEVICE REMOVAL DUE TO PAIN AND POSSIBLE PERFORATION. UPON HYSTEROSCOPY AND LAPAROSCOPY, THE DEVICES WERE FOUND TO BE IN NORMAL POSITION WITHIN THE FALLOPIAN TUBES AND NOT PERFORATED. THE PHYSICIAN PROCEEDED WITH BILATERAL SALPINGECTOMIES. THERE WAS INFLAMMATION, HYPERVASCULARITY AND POSSIBLE ENDOMETRIOSIS NOTED DURING LAPAROSCOPY. PHYSICIAN NOTED THAT IT IS STILL UNCLEAR WHY THIS PT HAD A SUDDEN ONSET OF RIGHT SIDE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS CONCEPTUS, INC. ESS205 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other