BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 17049587 · Received June 2, 2023

    Report

    Report Number
    2951250-2023-02584
    Event Type
    Injury
    Date Received
    June 2, 2023
    Report Date
    June 15, 2023
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 30-MAY-2023. THE MOST RECENT INFORMATION WAS RECEIVED ON 14-JUN-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("LOW BACK PAIN") IN A 45 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 945070). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013 SHE EXPERIENCED MYALGIA ("MUSCLE PAIN"), ARTHRALGIA ("JOINT PAIN / PERSISTENT CURRENT PAIN IN THE LEFT SHOULDER") AND NECK PAIN ("NECK PAIN / CERVICAL PAIN"). AN UNKNOWN TIME LATER SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), PAIN IN EXTREMITY ("LEFT ARM PAIN"), FATIGUE ("FATIGUE"), DIZZINESS ("DIZZINESS"), SLUGGISHNESS ("SLUGGISH HEAD FEELING"), VISUAL IMPAIRMENT ("VISUAL DISTURBANCES"), IRRITABILITY ("IRRITATED") AND SWELLING OF EYELID ("SWOLLEN EYELIDS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE BACK PAIN, ARTHRALGIA, NECK PAIN AND PAIN IN EXTREMITY HAD NOT RESOLVED. THE OUTCOMES FOR MYALGIA, FATIGUE, DIZZINESS, SLUGGISHNESS, VISUAL IMPAIRMENT, IRRITABILITY AND SWELLING OF EYELID WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO MYALGIA, ARTHRALGIA, NECK PAIN, PAIN IN EXTREMITY, BACK PAIN, FATIGUE, DIZZINESS, SLUGGISHNESS, VISUAL IMPAIRMENT, IRRITABILITY OR SWELLING OF EYELID. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 70 KG. [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): MEDICAL TESTS DUE PERSISTENTE CURRENT PAIN IN THE LEFT SHOULDER, LEFT ARM, LOW BACK AND NECK [MAGNETIC RESONANCE IMAGING] (DATE UNKNOWN): MEDICAL TESTS DUE PERSISTENTE CURRENT PAIN IN THE LEFT SHOULDER, LEFT ARM, LOW BACK AND NECK [X-RAY] (DATE UNKNOWN): MEDICAL TESTS DUE PERSISTENTE CURRENT PAIN IN THE LEFT SHOULDER, LEFT ARM, LOW BACK AND NECK. LOT NUMBER: 945070 MANUFACTURE DATE: 2012-01 EXPIRATION DATE: 2015-01. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 14-JUN-2023: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. 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 · 0

    THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 30-MAY-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("LOW BACK PAIN") IN A 45 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 945070). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013 SHE EXPERIENCED MYALGIA ("MUSCLE PAIN"), ARTHRALGIA ("JOINT PAIN / PERSISTENT CURRENT PAIN IN THE LEFT SHOULDER") AND NECK PAIN ("NECK PAIN / CERVICAL PAIN"). AN UNKNOWN TIME LATER SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), PAIN IN EXTREMITY ("LEFT ARM PAIN"), FATIGUE ("FATIGUE"), DIZZINESS ("DIZZINESS"), SLUGGISHNESS ("SLUGGISH HEAD FEELING"), VISUAL IMPAIRMENT ("VISUAL DISTURBANCES"), IRRITABILITY ("IRRITATED") AND SWELLING OF EYELID ("SWOLLEN EYELIDS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE BACK PAIN, ARTHRALGIA, NECK PAIN AND PAIN IN EXTREMITY HAD NOT RESOLVED. THE OUTCOMES FOR MYALGIA, FATIGUE, DIZZINESS, SLUGGISHNESS, VISUAL IMPAIRMENT, IRRITABILITY AND SWELLING OF EYELID WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO MYALGIA, ARTHRALGIA, NECK PAIN, PAIN IN EXTREMITY, BACK PAIN, FATIGUE, DIZZINESS, SLUGGISHNESS, VISUAL IMPAIRMENT, IRRITABILITY OR SWELLING OF EYELID. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 70 KG. [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): MEDICAL TESTS DUE PERSISTENTE CURRENT PAIN IN THE LEFT SHOULDER, LEFT ARM, LOW BACK AND NECK [MAGNETIC RESONANCE IMAGING] (DATE UNKNOWN): MEDICAL TESTS DUE PERSISTENTE CURRENT PAIN IN THE LEFT SHOULDER, LEFT ARM, LOW BACK AND NECK [X-RAY] (DATE UNKNOWN): MEDICAL TESTS DUE PERSISTENT CURRENT PAIN IN THE LEFT SHOULDER, LEFT ARM, LOW BACK AND NECK. 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
    971993 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 945070 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other