BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2181194 · Received July 21, 2011

    Report

    Report Number
    2951250-2011-00042
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    March 1, 2009
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS

    Description of Event or Problem · 1

    PATIENT REPORT OF PAIN, POST-ESSURE PLACEMENT (IMPLANTED (B)(6) 2008). PAIN STARTED ABOUT 1 YEAR POST PLACEMENT; EXPLORATORY LAPAROSCOPIC SURGERY IN (B)(6) 2010 AND FOUND SCAR TISSUE ATTACHED TO THE BOWEL AND REMOVED IT. THE PATIENT SAID THE PAIN SUBSIDED FOR ABOUT 6 MONTHS AND THEN STARTED UP AGAIN IN (B)(6) OF 2010, INCLUDING PAINFUL MENSTRUAL CYCLES AND WAS GIVEN DEPO TO HELP ALLEVIATE THE PAIN. ON (B)(6), 2011, DR (B)(6) DID A HYSTERECTOMY AND REMOVED THE UTERUS AND FALLOPIAN TUBES. MICRO-INSERTS HAD PERFORATED BOTH TUBES, AND THAT MOST LIKELY THAT WAS THE SOURCE OF HER PAIN. FOLLOW UP WITH PATIENT (B)(6) 2011, WHO REPORTS RESOLUTION OF PAIN SINCE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention