BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8670806 · Received June 5, 2019

    Report

    Report Number
    2951250-2019-02546
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    December 1, 2006
    Report Date
    June 5, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL),') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ABDOMINAL PAIN, VAGINAL DISCHARGE, SECOND TRIMESTER PREGNANCY, SEXUALLY TRANSMITTED DISEASE, GALLBLADDER REMOVAL AND VAGINITIS BACTERIAL. CONCURRENT CONDITIONS INCLUDED GESTATIONAL DIABETES, OBESITY, BACK PAIN, URINARY URGENCY, MALAISE, FEVER, MENORRHAGIA, UTERINE ENLARGEMENT, FIBROIDS, MENSTRUAL DISORDER, VAGINAL PAIN, UTERINE BLEEDING AND VENEREAL DISEASE NOS. IN (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2006, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,") AND NAUSEA ("NAUSEA."). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, MIGRAINE, HEADACHE AND NAUSEA HAD RESOLVED AND THE URINARY TRACT DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MIGRAINE, NAUSEA AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: *DISCREPANCY NOTED IN INSERTION DATE- (B)(6) 2005., DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON (B)(6) 2005: ULTRASOUND REPRESENTS A RIGHT FUNDAL SUBSEROSAL FIBROID AS ABOVE.; IN 2006: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAY-2019: NEW PFS + MR RECEIVED- NEW EVENTS ADDED: ABNORMAL BLEEDING (GENERAL), BLADDER OR URINARY PROBLEMS OR CHANGES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MIGRAINES / HEADACHES, NAUSEA WERE ADDED. CONCOMITANT AND HISTORICAL CONDITIONS WERE ADDED. NEW REPORTERS AND DOB WERE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465978 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R