BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 19604154 · Received June 25, 2024

    Report

    Report Number
    2951250-2024-00446
    Event Type
    Injury
    Date Received
    June 25, 2024
    Report Date
    June 28, 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

    THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 19-JUN-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 27-JUN-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL DISTENSION ("BLOATING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 904749, 915892-NOT VALID) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON 25-MAY-2012, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATE SHE EXPERIENCED ABDOMINAL DISTENSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ANAEMIA ("ANAEMIA"), INSOMNIA ("DIFFICULTY SLEEPING"), ARTHRALGIA ("MUSCLE AND JOINT PAIN"), DIZZINESS ("DIZZINESS") AND PARAESTHESIA ("PARESTHESIA"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). ESSURE WAS REMOVED ON 31-MAY-2024. AT THE TIME OF THE REPORT, THE OUTCOMES FOR ABDOMINAL DISTENSION, ANAEMIA, INSOMNIA, ARTHRALGIA AND DIZZINESS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ANAEMIA, INSOMNIA, ARTHRALGIA, DIZZINESS, PARAESTHESIA OR ABDOMINAL DISTENSION. LOT NUMBER: 904749, MANUFACTURE DATE: 2011-09, EXPIRATION DATE: 2014-09. LOT NUMBER: 915892 IS NOT VALID. 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: 27-JUN-2024: 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 19-JUN-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL DISTENSION ("BLOATING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 904749, 915892) FOR FEMALE STERILIZATION. 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. ESSURE WAS REMOVED ON (B)(6) 2024. ON UNKNOWN DATE SHE EXPERIENCED ABDOMINAL DISTENSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ANAEMIA ("ANAEMIA"), INSOMNIA ("DIFFICULTY SLEEPING"), ARTHRALGIA ("MUSCLE AND JOINT PAIN"), DIZZINESS ("DIZZINESS") AND PARAESTHESIA ("PARESTHESIA"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE ). AT THE TIME OF THE REPORT, THE OUTCOMES FOR ABDOMINAL DISTENSION, ANAEMIA, INSOMNIA, ARTHRALGIA AND DIZZINESS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ANAEMIA, INSOMNIA, ARTHRALGIA, DIZZINESS, PARAESTHESIA OR ABDOMINAL DISTENSION. 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
    218016 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 904749, 915892-NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention