BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 20367318 · Received October 4, 2024

    Report

    Report Number
    2951250-2024-00600
    Event Type
    Injury
    Date Received
    October 4, 2024
    Report Date
    October 8, 2024
    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

    BAYER CASE NUMBER: (B)(4) PELVIC PAIN [PELVIC PAIN FEMALE] JOINT PROBLEMS [JOINT DISORDER] ABDOMINAL PAIN [ABDOMINAL PAIN] LOWER BACK PAIN [LOW BACK PAIN] TIREDNESS [TIREDNESS] DEPRESSION [DEPRESSION] ANXIETY [ANXIETY] DIGESTIVE PROBLEMS [DIGESTION IMPAIRED] MUSCLE PROBLEMS [MUSCLE DISORDER] FIBROMYALGIA [FIBROMYALGIA] HANDICAP [HANDICAP] CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 27-SEP-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 08-OCT-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND ARTHROPATHY ("JOINT PROBLEMS") IN A 50-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 945069) FOR FEMALE STERILISATION. 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. ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ARTHROPATHY (SERIOUSNESS CRITERION DISABILITY), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("LOWER BACK PAIN"), FATIGUE ("TIREDNESS"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), DYSPEPSIA ("DIGESTIVE PROBLEMS"), MUSCLE DISORDER ("MUSCLE PROBLEMS"), FIBROMYALGIA ("FIBROMYALGIA") AND DISABILITY ("HANDICAP"). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO FATIGUE, DEPRESSION, ANXIETY, DYSPEPSIA, ARTHROPATHY, MUSCLE DISORDER, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, FIBROMYALGIA OR DISABILITY. THE REPORTER COMMENTED: INTERVENTIONAL PROCEDURE: VISUALIZATION OF THE TWO OSTIA. EASY PLACEMENT OF AN ESSURE ON THE RIGHT AND LEFT WITH 3 TURNS OF THE OUTER COIL. COMMENTS "IN THE PROCESS OF REMOVAL, LOOKING FOR A GYNECOLOGIST CAPABLE OF CARRYING OUT THE REMOVAL WITH FULL KNOWLEDGE OF THE FACTS AND WHO WOULD FOLLOW THE REMOVAL PROTOCOL (MINISTRY OF HEALTH) THE FACILITY WHERE THE INSERTION TOOK PLACE NEVER SENT ME ANY MAIL ABOUT THIS, NOR DID THE SOCIAL SECURITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 90 KG. LOT NUMBER: 945069 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: 08-OCT-2024: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: 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

    BAYER CASE NUMBER: (B)(4), PELVIC PAIN [PELVIC PAIN FEMALE], JOINT PROBLEMS [JOINT DISORDER], ABDOMINAL PAIN [ABDOMINAL PAIN], LOWER BACK PAIN [LOW BACK PAIN], TIREDNESS [TIREDNESS], DEPRESSION [DEPRESSION], ANXIETY [ANXIETY], DIGESTIVE PROBLEMS [DIGESTION IMPAIRED], MUSCLE PROBLEMS [MUSCLE DISORDER], FIBROMYALGIA [FIBROMYALGIA], HANDICAP [HANDICAP], CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 27-SEP-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND ARTHROPATHY ("JOINT PROBLEMS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO: 945069) FOR FEMALE STERILISATION. 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. ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ARTHROPATHY (SERIOUSNESS CRITERION DISABILITY), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("LOWER BACK PAIN"), FATIGUE ("TIREDNESS"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), DYSPEPSIA ("DIGESTIVE PROBLEMS"), MUSCLE DISORDER ("MUSCLE PROBLEMS"), FIBROMYALGIA ("FIBROMYALGIA") AND DISABILITY ("HANDICAP"). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO FATIGUE, DEPRESSION, ANXIETY, DYSPEPSIA, ARTHROPATHY, MUSCLE DISORDER, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, FIBROMYALGIA OR DISABILITY. THE REPORTER COMMENTED: INTERVENTIONAL PROCEDURE: VISUALIZATION OF THE TWO OSTIA. EASY PLACEMENT OF AN ESSURE ON THE RIGHT AND LEFT WITH 3 TURNS OF THE OUTER COIL. COMMENTS "IN THE PROCESS OF REMOVAL, LOOKING FOR A GYNECOLOGIST CAPABLE OF CARRYING OUT THE REMOVAL WITH FULL KNOWLEDGE OF THE FACTS AND WHO WOULD FOLLOW THE REMOVAL PROTOCOL (MINISTRY OF HEALTH) THE FACILITY WHERE THE INSERTION TOOK PLACE NEVER SENT ME ANY MAIL ABOUT THIS, NOR DID THE SOCIAL SECURITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 90 KG. CASE COMMENTS: 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
    1325825 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 945069 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| S