BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1085184 · Received July 28, 2008

    Report

    Report Number
    2951250-2008-00017
    Event Type
    Other
    Date Received
    July 28, 2008
    Date of Event
    June 29, 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
    WI, 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 THAT A PT WHO HAD ESSURE PLACED IN 2006 PRESENTED WITH A COMPLAINT OF PERSISTENT PAIN. PHYSICIAN REMOVED BOTH MICROINSERTS VIA LAPAROSCOPY WITHOUT EVENT. NO FURTHER INFO PROVIDED BY PHYSICIAN.

    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