BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1466320 · Received September 3, 2009

    Report

    Report Number
    2951250-2009-00050
    Event Type
    Other
    Date Received
    September 3, 2009
    Date of Event
    July 16, 2009
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDICAL DEVICE REPORT IDENTIFIES A SECOND ECTOPIC PREGNANCY, POST ESSURE, FOR THE SAME PT. THE FIRST ECTOPIC PREGNANCY WAS REPORTED AS: MDR 2951250-2009-00049.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN REPORTED AN ECTOPIC PREGNANCY FOR A PT THAT UNDERWENT THE ESSURE MICRO-INSERT PLACEMENT PROCEDURE ON (B)(6)2008. PT DID NOT RETURN FOR AN ESSURE CONFIRMATION TEST (HSG). ON (B)(6)2009, PT WAS TREATED WITH METHOTREXATE; PREGNANCY WAS TERMINATED. ON (B)(6)2009, PT WAS SEEN BY HER PHYSICIAN FOR FOLLOW UP, POST-TREATMENT. ON (B)(6)2009, PHYSICIAN'S NURSE REPORTED THAT PT IS DOING WELL.

    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