BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9744509 · Received February 24, 2020

    Report

    Report Number
    2951250-2020-01649
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    January 1, 2012
    Report Date
    March 9, 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 (B)(6) 2020. THE MOST RECENT INFORMATION WAS RECEIVED ON 06-MAR-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('INTENSE ABDOMINAL PAIN') AND BACK PAIN ('INTENSE BACK PAIN') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED FOR TUBAL LIGATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HAEMORRHAGIC PERIODS"), HEADACHE ("HEADACHES"), PAIN IN EXTREMITY ("PAIN IN THE HANDS"), ARTHRALGIA ("JOINT PAIN IN SEVERAL PARTS OF THE BODY"), LIGAMENT PAIN ("LIGAMENT PAIN IN SEVERAL PARTS OF THE BODY"), DYSPNOEA ("DIFFICULTY BREATHING") AND CHEST PAIN ("PERMANENT CHEST PAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, HEADACHE, PAIN IN EXTREMITY, ARTHRALGIA, LIGAMENT PAIN, DYSPNOEA AND CHEST PAIN HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, CHEST PAIN, DYSPNOEA, HEADACHE, LIGAMENT PAIN, MENORRHAGIA AND PAIN IN EXTREMITY WITH ESSURE. LOT NUMBER: 852008, MANUFACTURING DATE: 2011-04, EXPIRATION DATE: 2014-04 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-MAR-2020: QUALITY SAFETY EVALUATION OF PTC. A TECHNICAL INVESTIGATION WAS 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.

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), REFERENCE NUMBER: (B)(4)) ON 20-FEB-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('INTENSE ABDOMINAL PAIN') AND BACK PAIN ('INTENSE BACK PAIN') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852008) INSERTED FOR STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("HAEMORRHAGIC PERIODS"), HEADACHE ("HEADACHES"), PAIN IN EXTREMITY ("PAIN IN THE HANDS"), ARTHRALGIA ("JOINT PAIN IN SEVERAL PARTS OF THE BODY"), LIGAMENT PAIN ("LIGAMENT PAIN IN SEVERAL PARTS OF THE BODY"), DYSPNOEA ("DIFFICULTY BREATHING") AND CHEST PAIN ("PERMANENT CHEST PAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, HEADACHE, PAIN IN EXTREMITY, ARTHRALGIA, LIGAMENT PAIN, DYSPNOEA AND CHEST PAIN HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, CHEST PAIN, DYSPNOEA, HEADACHE, LIGAMENT PAIN, MENORRHAGIA AND PAIN IN EXTREMITY WITH ESSURE. 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
    210832 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 852008 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other