BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1062838 · Received June 16, 2008

    Report

    Report Number
    2951250-2008-00014
    Event Type
    Other
    Date Received
    June 16, 2008
    Date of Event
    March 1, 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
    VA, 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 PATIENT WHO COMPLAINED OF DYSMENORRHEA AND DYSPAREUNIA. PATIENT UNDERWENT ESSURE PROCEDURE SIX WEEKS POSTPARTUM BY ANOTHER PHYSICIAN. PT DELIVERED VIA C-SECTION PRIOR TO PLACEMENT. HSG WAS REPORTED TO BE "NORMAL" BUT PHYSICIAN HAS NOT REVIEWED FILMS. PT UNDERWENT A LAPAROSCOPY IN 2008, WHICH SHOWED AN ENLARGED UTERUS AND ADENOMYOSIS. PT THEN UNDERWENT A HYSTERECTOMY 2008. PHYSICIAN DID NOT SEE ANY SIGN OF PERFORATION DURING THE HYSTERECTOMY. THE PATHOLOGY REPORT SHOWED NORMAL FINDINGS; PHYSICIAN BELIEVES THAT PAIN MAY HAVE BEEN RELATED TO ESSURE. PT'S PAIN RESOLVED FOLLOWING HYSTERECTOMY.

    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