BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1047461 · Received May 16, 2008

    Report

    Report Number
    2951250-2008-00008
    Event Type
    Other
    Date Received
    May 16, 2008
    Date of Event
    October 10, 2007
    Report Date
    February 14, 2017
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 MICRO-INSERTS WERE PLACED POST PARTUM. PT STARTED TO EXPERIENCE SEVERE PAIN AND HAD THEM REMOVED BY ANOTHER PHYSICIAN. NO INFO WAS ABLE TO BE OBTAINED FROM THE PHYSICIAN WHO REMOVED THE DEVICES.

    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