BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 15796498 · Received November 15, 2022

    Report

    Report Number
    2951250-2022-01320
    Event Type
    Injury
    Date Received
    November 15, 2022
    Report Date
    November 21, 2022
    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) 2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 17-NOV-2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("BACK PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 626916). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED (INTRA-UTERINE). AN UNKNOWN TIME LATER SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), HEADACHE ("HEADACHES"), PAIN IN EXTREMITY ("CALF PAIN"), ARTHRALGIA ("ANKLE PAIN"), COGNITIVE DISORDER ("COGNITIVE IMPAIRMENT"), VISUAL IMPAIRMENT ("VISUAL IMPAIRMENT"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL IMPAIRMENT"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCIES"), IRON DEFICIENCY ("IRON DEFICIENCIES"), DIABETES MELLITUS ("DIABETES"), HYPERTENSION ("HYPERTENSION"), BURNOUT SYNDROME ("BURNOUT"), FATIGUE ("CHRONIC FATIGUE") AND ASTHENIA ("ASTHENIA"). AT THE TIME OF THE REPORT, THE BACK PAIN, HEADACHE, PAIN IN EXTREMITY, ARTHRALGIA, COGNITIVE DISORDER, VISUAL IMPAIRMENT, GASTROINTESTINAL DISORDER, VITAMIN D DEFICIENCY, IRON DEFICIENCY, DIABETES MELLITUS AND HYPERTENSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ARTHRALGIA, ASTHENIA, BACK PAIN, BURNOUT SYNDROME, COGNITIVE DISORDER, DIABETES MELLITUS, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, HYPERTENSION, IRON DEFICIENCY, PAIN IN EXTREMITY, VISUAL IMPAIRMENT AND VITAMIN D DEFICIENCY TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 72 KG. LOT NUMBER: 626916. MANUFACTURE DATE: 2006-04. EXPIRATION DATE: 2010-04. 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: 17-NOV-2022: 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 · 0

    THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON (B)(6) 2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("BACK PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 626916). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED (INTRA-UTERINE). AN UNKNOWN TIME LATER SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), HEADACHE ("HEADACHES"), PAIN IN EXTREMITY ("CALF PAIN"), ARTHRALGIA ("ANKLE PAIN"), COGNITIVE DISORDER ("COGNITIVE IMPAIRMENT"), VISUAL IMPAIRMENT ("VISUAL IMPAIRMENT"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL IMPAIRMENT"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCIES"), IRON DEFICIENCY ("IRON DEFICIENCIES"), DIABETES MELLITUS ("DIABETES"), HYPERTENSION ("HYPERTENSION"), BURNOUT SYNDROME ("BURNOUT"), FATIGUE ("CHRONIC FATIGUE") AND ASTHENIA ("ASTHENIA"). AT THE TIME OF THE REPORT, THE BACK PAIN, HEADACHE, PAIN IN EXTREMITY, ARTHRALGIA, COGNITIVE DISORDER, VISUAL IMPAIRMENT, GASTROINTESTINAL DISORDER, VITAMIN D DEFICIENCY, IRON DEFICIENCY, DIABETES MELLITUS AND HYPERTENSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ARTHRALGIA, ASTHENIA, BACK PAIN, BURNOUT SYNDROME, COGNITIVE DISORDER, DIABETES MELLITUS, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, HYPERTENSION, IRON DEFICIENCY, PAIN IN EXTREMITY, VISUAL IMPAIRMENT AND VITAMIN D DEFICIENCY TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 72 KG. 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
    2704442 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 626916 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other