BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7934961 · Received October 4, 2018

    Report

    Report Number
    2951250-2018-04238
    Event Type
    Injury
    Date Received
    October 4, 2018
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: R1816627) ON 03-OCT-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PAIN ("PAIN THAT MIGRATED WITH NO CAUSE, FLEETING BUT UNCOMFORTABLE") AND SUICIDE ATTEMPT ("3 SUICIDE ATTEMPTS") IN A 51-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VISION BLURRED ("VISION MORE AND MORE BLURRED"), SUICIDE ATTEMPT (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEPRESSION ("HER DEPRESSION INCREASED"). AT THE TIME OF THE REPORT, THE PAIN, VISION BLURRED, SUICIDE ATTEMPT AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEPRESSION, PAIN, SUICIDE ATTEMPT AND VISION BLURRED WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 49 KGS. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-OCT-2018: PATIENT AND DEVICE PROBLEM CODES WERE ADDED. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: R1816627) ON (B)(6) -2018. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PAIN ("PAIN THAT MIGRATED WITH NO CAUSE, FLEETING BUT UNCOMFORTABLE") AND SUICIDE ATTEMPT ("3 SUICIDE ATTEMPTS") IN A 51-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VISION BLURRED ("VISION MORE AND MORE BLURRED"), SUICIDE ATTEMPT (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEPRESSION ("HER DEPRESSION INCREASED"). AT THE TIME OF THE REPORT, THE PAIN, VISION BLURRED, SUICIDE ATTEMPT AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEPRESSION, PAIN, SUICIDE ATTEMPT AND VISION BLURRED WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 49 KGS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) -2018: QUALITY SAFETY EVALUATION OF PTC INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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.

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), (B)(4)) ON 03-OCT-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PAIN ("PAIN THAT MIGRATED WITH NO CAUSE, FLEETING BUT UNCOMFORTABLE") AND SUICIDE ATTEMPT ("3 SUICIDE ATTEMPTS") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VISION BLURRED ("VISION MORE AND MORE BLURRED"), SUICIDE ATTEMPT (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEPRESSION ("HER DEPRESSION INCREASED"). AT THE TIME OF THE REPORT, THE PAIN, VISION BLURRED, SUICIDE ATTEMPT AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEPRESSION, PAIN, SUICIDE ATTEMPT AND VISION BLURRED WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): (B)(6). FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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
    774183 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other