BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16528356 · Received March 13, 2023

    Report

    Report Number
    2951250-2023-01153
    Event Type
    Injury
    Date Received
    March 13, 2023
    Report Date
    March 20, 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 (B)(6) 2023. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("BACK PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 945069). 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. AN UNKNOWN TIME LATER SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), MEMORY IMPAIRMENT ("MEMORY DISORDERS"), ALOPECIA ("HAIR LOSS"), SLEEP DISORDER ("SLEEP DISORDER"), DRY EYE ("DRY EYES") AND APHASIA ("APHASIA"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MEMORY IMPAIRMENT HAD NOT RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO BACK PAIN, MEMORY IMPAIRMENT, ALOPECIA, SLEEP DISORDER, DRY EYE OR APHASIA. THE REPORTER COMMENTED: NOT A DAY GOES BY WITHOUT MY MEMORY DISORDERS INTERFERING WITH MY DAILY LIFE, I HAVE TO WRITE EVERYTHING DOWN AND I AM CONSTANTLY APOLOGISING TO THOSE AROUND ME FOR MY OVERSIGHTS, MY REPETITIONS, ETC. MEMORY DISORDERS THAT LED TO A DAY OF MEDICAL EXAMINATIONS IN THE HOSPITAL IN 2015 TO DETERMINE THE CAUSE (NO PROBLEM DETECTED, THEREFORE CONCLUSION OF MENTAL OVERLOAD). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KG. LOT NUMBER: 945069 MANUFACTURE DATE: (B)(6) 2012 EXPIRATION DATE: (B)(6) 2015. 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: (B)(6) 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 (B)(6) 2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("BACK PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 945069). 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. AN UNKNOWN TIME LATER SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), MEMORY IMPAIRMENT ("MEMORY DISORDERS"), ALOPECIA ("HAIR LOSS"), SLEEP DISORDER ("SLEEP DISORDER"), DRY EYE ("DRY EYES") AND APHASIA ("APHASIA"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MEMORY IMPAIRMENT HAD NOT RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO BACK PAIN, MEMORY IMPAIRMENT, ALOPECIA, SLEEP DISORDER, DRY EYE OR APHASIA. THE REPORTER COMMENTED: NOT A DAY GOES BY WITHOUT MY MEMORY DISORDERS INTERFERING WITH MY DAILY LIFE, I HAVE TO WRITE EVERYTHING DOWN AND I AM CONSTANTLY APOLOGISING TO THOSE AROUND ME FOR MY OVERSIGHTS, MY REPETITIONS, ETC. MEMORY DISORDERS THAT LED TO A DAY OF MEDICAL EXAMINATIONS IN THE HOSPITAL IN 2015 TO DETERMINE THE CAUSE (NO PROBLEM DETECTED, THEREFORE CONCLUSION OF MENTAL OVERLOAD). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KG. 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
    449071 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 945069 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other