BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 12423801 · Received September 3, 2021

    Report

    Report Number
    2951250-2021-03154
    Event Type
    Injury
    Date Received
    September 3, 2021
    Report Date
    September 3, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 ('DISPLACED ESSURE CONTRACEPTIVE DEVICES') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940971) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PAIN, GENITAL HAEMORRHAGE, OVARIAN CYST, ADENOMYOSIS, IRON DEFICIENCY ANEMIA AND MENOMETRORRHAGIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ALLERGY TO METALS ("NICKEL ALLERGY"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), NAUSEA ("NAUSEA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND PELVIC PAIN ("CHRONIC PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY,DIAGNOSTIC HYSTEROSCOPY, ESSURE RESECTION). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DYSPAREUNIA, HEAVY MENSTRUAL BLEEDING, ALLERGY TO METALS, VAGINAL DISCHARGE, VAGINAL INFECTION, FATIGUE, ALOPECIA, GASTROINTESTINAL DISORDER, NAUSEA, MIGRAINE, HEADACHE, WEIGHT INCREASED AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, DEVICE DISLOCATION, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2013: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) RESULT NOT REPORTED. ULTRASOUND SCAN - ON AN UNKNOWN DATE: TRANSVAGINAL IMAGES WERE OBTAINED- IMPRESSION: PELVIC ULTRASOUND FINDINGS INCLUDE NORMAL OVARIES BILATERALLY. A SMALL FOLLICULAR TYPE IS SEEN IN THE RIGHT OVARY. THE UTERUS IS NORMAL SIZED, RETROVERTED AND WITHOUT ANY PATHOLOGICAL FINDINGS. THE ENDOMETRIUM IS VERY THIN WITH NO OBVIOUS ABNORMALITY. LOT NUMBER: 940971. MANUFACTURING DATE: 2012-01. EXPIRATION DATE: 2015-01 . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-AUG-2021: MR RECEIVED-EVENT DISPLACED ESSURE CONTRACEPTIVE DEVICES WERE ADDED. NEW REPORTER, MEDICAL HISTORY, REMOVAL DETAILS WERE ADDED WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT 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
    1318487 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 940971 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R