BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7960995 · Received October 12, 2018

    Report

    Report Number
    2951250-2018-04300
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    April 1, 2017
    Report Date
    October 12, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE DEVICE/RIGHT NOT IN TUBE/ MIGRATION OF ESSURE DEVICE, LOCATION OF DEVICE: LEFT PELVIS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED UTERINE BLEEDING, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE ENLARGEMENT, MENORRHAGIA, OBESITY AND OVARIAN MASS. CONCOMITANT PRODUCTS INCLUDED NSAID'S. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES: FREQUENT URINATION"), ANXIETY ("MENTAL ANGUISH") AND DEPRESSION ("DEPRESSION,"). IN 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN") AND NAUSEA ("NAUSEA"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN/PAIN/LOWER LEFT SIDE PAIN"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2017, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION TYPE: UTI"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND ALTERNATIVE THERAPY (19 TEETH REMOVED). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, DYSMENORRHOEA, FATIGUE, WEIGHT INCREASED AND NAUSEA OUTCOME WAS UNKNOWN, THE POLLAKIURIA AND TOOTH DISORDER HAD RESOLVED AND THE ANXIETY AND DEPRESSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, FATIGUE, HEADACHE, MIGRAINE, NAUSEA, PELVIC PAIN, POLLAKIURIA, TOOTH DISORDER, URINARY TRACT INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2017: TOTAL BILATERAL OCCLUSION. (B)(6) 2017: THAT ONLY ONE TUBE WAS OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED- NEW EVENT DEPRESSION, MENTAL ANGUISH WERE ADDED. OUTCOME OF BLADDER PROBLEMS, DENTAL PROBLEMS UPDATED TO RECOVERED / RESOLVED. INCIDENT. AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802776 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893029 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other NSAID'S (NSAID'S) ONGOING