BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1085183 · Received July 28, 2008

    Report

    Report Number
    2951250-2008-00016
    Event Type
    Other
    Date Received
    July 28, 2008
    Date of Event
    July 2, 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
    PA, 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 PERFORMED APPROX ONE YR AGO. HSG DOCUMENTED BILATERAL TUBAL OCCLUSION. PREGNANCY REPORTED BY PHYSICIAN IN 2008. AN ULTRASOUND REVEALED A SAC IN THE UTERUS WITHOUT THE PRESENCE OF A FETAL POLE. AT 2-3 WEEKS LATER, PT EXPERIENCED SIGNIFICANT BLEEDING, SO A SUPERCERVICAL HYSTERECTOMY WAS PERFORMED TO TREAT THE MENORRHAGIA THOUGHT TO BE ASSOCIATED WITH A BLIGHTED OVUM AND SAB. UPON LAPAROSCOPY, THE RIGHT DEVICE WAS FOUND TO BE PERFORATED AT THE CORNUA, AND THROUGH THE MYOMETRIUM. PT ALSO HAD A LARGE ECTOPIC THAT WAS REMOVED AT THIS TIME. PT WAS ASYMPTOMATIC REGARDING THE ECTOPIC PREGNANCY. PT IS DOING FINE POST-OP. FOLLOWING THE SURGERY, PHYSICIAN REVIEWED THE HSG FILMS, AND NOTED THAT THE RIGHT DEVICE WAS CLEARLY PERFORATED. THE HSG AND SURGICAL FINDINGS WERE CONSISTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS CONCEPTUS, INC. ESS305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention