BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2980528 · Received February 21, 2013

    Report

    Report Number
    2951250-2013-00006
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    July 5, 2012
    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
    FR
    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

    THE ESSURE WAS DONE ON (B)(6) 2012. AN IUD WHICH WAS SUPPOSED TO BE IN PLACE WAS NOT VISIBLE DURING THE HYSTEROSCOPY. THE PATIENT'S LAST PERIOD PRIOR TO IMPLANT WAS ON (B)(6) 2012. ON (B)(6) 2012, A PREGNANCY WAS CONFIRMED FOR THE PATIENT. ON (B)(6) 2012, SHE WAS HOSPITALIZED IN THE EMERGENCY UNIT BECAUSE AN ECTOPIC PREGNANCY WAS DETECTED AND SHE WAS EXPERIENCING SEVERE PAIN. AN EMERGENCY SALPINGECTOMY WAS DONE THE SAME DAY. THE IMPLANT PHYSICIAN BELIEVES THE IMPLANTS WERE PLACED CORRECTLY, BUT SUSPECTS THAT THE PATIENT WAS PREGNANT THE DAY OF THE PROCEDURE AND THAT THIS WAS A CONTRIBUTING FACTOR IN THE PREGNANCY DEVELOPING ECTOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75477 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R