BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8662101 · Received June 3, 2019

    Report

    Report Number
    2951250-2019-02395
    Event Type
    Injury
    Date Received
    June 3, 2019
    Report Date
    June 3, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5086655) ON 23-MAY-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED SERTRALINE. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA HOSPITALIZATION, DISABILITY AND INTERVENTION REQUIRED), EXPERIENCED RASH ("RASH ON FACE"), HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES"), THINKING ABNORMAL ("FOGGY THINKING"), DEPRESSION ("DEPRESSION"), ACNE CYSTIC ("CYSTIC ACNE"), DRY SKIN ("EXTREME DRY SKIN"), ECZEMA ("ECZEMA"), VISION BLURRED ("BLURRY VISION"), FATIGUE ("FATIGUE") AND MENOPAUSE ("PERI MENOPAUSE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("FEMALE HORMONE IMBALANCE"). THE PATIENT WAS TREATED WITH HORMONES AND SURGERY (ESSURE WAS REMOVED). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, RASH, HEADACHE, MIGRAINE, THINKING ABNORMAL, DEPRESSION, HORMONE LEVEL ABNORMAL, ACNE CYSTIC, DRY SKIN, ECZEMA, VISION BLURRED, FATIGUE AND MENOPAUSE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ACNE CYSTIC, DEPRESSION, DRY SKIN, ECZEMA, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, MEDICAL DEVICE REMOVAL, MENOPAUSE, MIGRAINE, RASH, THINKING ABNORMAL AND VISION BLURRED WITH ESSURE. INCIDENT: NO LOT NUMBER 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
    455275 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S SERTRALINE