BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10631501 · Received October 5, 2020

    Report

    Report Number
    2951250-2020-14786
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    September 18, 2020
    Report Date
    October 8, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON 02-OCT-2020. THE MOST RECENT INFORMATION WAS RECEIVED ON 07-OCT-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED HYPERACUSIS ("HYPERACUSIS"), TINNITUS ("TINNITUS"), TENDONITIS ("CHRONIC TENDONITIS") AND VISUAL IMPAIRMENT ("DECREASED VISION"). ON (B)(6) 2020, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 9 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL) AND QUASI-IMMOBILISATION. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE HYPERACUSIS, TINNITUS, TENDONITIS AND VISUAL IMPAIRMENT WAS RESOLVING. THE REPORTER CONSIDERED HYPERACUSIS, MEDICAL DEVICE REMOVAL, TENDONITIS, TINNITUS AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-OCT-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6) ON 02-OCT-2020, REFERENCE NUMBER: (B)(4)). THIS SPONTANEOUS CASE WAS REPORTED BY A REGULATORY AUTHORITY AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED HYPERACUSIS ("HYPERACUSIS"), TINNITUS ("TINNITUS"), TENDONITIS ("CHRONIC TENDONITIS") AND VISUAL IMPAIRMENT ("DECREASED VISION"). ON (B)(6) 2020, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 9 YEARS 7 MONTHS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL) AND QUASI-IMMOBILIZATION FOR THE TENDONITIS. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE HYPERACUSIS, TINNITUS, TENDONITIS AND VISUAL IMPAIRMENT WAS RESOLVING. THE REPORTER CONSIDERED HYPERACUSIS, MEDICAL DEVICE REMOVAL, TENDONITIS, TINNITUS AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091739 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R