BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1053567 · Received May 22, 2008

    Report

    Report Number
    2951250-2008-00010
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    January 22, 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
    FR
    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

    PATIENT HAD CONCURRENT ESSURE PROCEDURE AND IMPLANON REMOVAL ON (B) (6) 2007. BOTH OSTIA VISUALIZED WELL AND 4 TRAILING COILS NOTED ON BOTH SIDES. AFTER THE PROCEDURE, PATIENT PRESENTED DIFFERENT SYMPTOMS: NAUSEA, SHIVERING, AND DISCOMFORT, SOMETIMES ASSOCIATED WITH ILIAC PAIN ON THE RIGHT SIDE. PATIENT ALSO HAD A NICKEL ALLERGY CONFIRMED. ON (B) (6) 2008, THE PATIENT HAD A HYSTEROSCOPY AND A LAPAROSCOPY TO REMOVE BOTH TUBES. RESULT FROM HYSTEROSCOPY: THE CAVITY APPEARS NORMAL. THE ENDOMETRIUM IS PALE, WITH SOME TISSUES. NO POLYPE, AND NOTHING ABNORMAL. A BIOPSY WAS DONE WITH A CURETTE. RESULT FROM LAPAROSCOPY: ABDOMINAL CAVITY EXPLORED WITH FOCUS ON THE RIGHT SIDE. THE UTERUS WAS SLIGHTLY GLOBULAR WITH 2 HEALTHY ADNEXA. NO GRANULATION, NO INFLAMMATORY REACTION, NO ADHESION, NO ENDOMETRIOSIS NOTED. A BILATERAL SALPINGECTOMY WAS DONE. ENDOMETRIAL BIOPSY SHOWED AN HYPERPLASIA POLYP IN A PROLIFERATIVE PHASE. THE RIGHT TUBE HAD NO MACROSCOPIC ABNORMALITIES; THE LEFT TUBE HAD NO INFLAMMATORY SIGNS. SMALL BILATERAL HYPERPLASIA NOTED, WITH ATYPICAL SIGN AND NO DYSPLASIA.

    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