BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 1990722 · Received February 8, 2011

    Report

    Report Number
    2951250-2011-00007
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    November 29, 2010
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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

    ON (B)(6) 2010 REPORT, THAT PT HAS 2 INSERTS IN 1 TUBE; NO DETACHMENT DIFFICULTY. PT IS NOW COMPLAINING OF PAIN ON THAT SIDE. PHYSICIAN WILL PERFORM A SALPINGECTOMY AND REMOVE DEVICES ON THAT SIDE (SCHEDULED FOR (B)(6) 2010); PHYSICIAN ATTRIBUTES PAIN TO THE DEVICES; ULTRASOUND PERFORMED AND APPEARS 1 DEVICE ON THAT SIDE IS FOLDED ON ITSELF. FOLLOW UP CONFIRMED THAT SALPINGECTOMY WAS PERFORMED ON RIGHT SIDE AND LIGATION OF LEFT SIDE ON (B)(6) 2010. NO MICRO-INSERTS REMOVED. PAIN CONTINUED AND X-RAY WAS PERFORMED ON (B)(6) 2010. TWO MICRO-INSERTS WERE OBSERVED IN THE UTERINE AREA, SO SHE WAS TAKEN TO SURGERY AGAIN ON (B)(6) 2010; HYSTERECTOMY PERFORMED AND LEFT FALLOPIAN TUBE WAS REMOVED; ALSO REMOVED 3 MICRO-INSERTS: 1 IN THE TUBAL MYOMETRIAL JUNCTION AND 2 MORE IN THE UTERUS. PHYSICIAN BELIEVES THAT THE ESSURE DEVICES MAY HAVE CONTRIBUTED TO PT'S PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 709952

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention