BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1062837 · Received June 16, 2008

    Report

    Report Number
    2951250-2008-00012
    Event Type
    Other
    Date Received
    June 16, 2008
    Date of Event
    June 4, 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
    TX, 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

    PHYSICIAN REPORTED A PT WHO WAS DIAGNOSED WITH AN ECTOPIC PREGNANT REQUIRING INTERVENTION APPROX 6-MONTHS POST-ESSURE MICRO-INSERT PLACEMENT. PT DID NOT RETURN FOR THE REQUIRED ESSURE CONFIRMATION TESTS.

    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 Life Threatening| R