BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 18117938 · Received November 13, 2023

    Report

    Report Number
    2951250-2023-03294
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    January 1, 2014
    Report Date
    February 1, 2024
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    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 08-NOV-2023. THE MOST RECENT INFORMATION WAS RECEIVED ON 31-JAN-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("ESSURE DEVICES BROKEN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. A27184) FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), AMNESIA ("MEMORY LOSS"), DYSPAREUNIA ("PAINFUL SEXUAL RELATIONS"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), DYSPNOEA ("SHORTNESS OF BREATH"), ARTHRALGIA ("JOINT PAIN") AND ABDOMINAL PAIN UPPER ("STOMACH PAIN ON THE LOWER LEFT SIDE OF THE ABDOMEN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE WAS REMOVED ON (B)(6) 2023. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DEVICE BREAKAGE, MIGRAINE, AMNESIA, DYSPAREUNIA, INTERMENSTRUAL BLEEDING, WEIGHT INCREASED, DYSPNOEA, ARTHRALGIA OR ABDOMINAL PAIN UPPER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 61 KG. [X-RAY] (DATE UNKNOWN): ESSURE DEVICES BROKEN. LOT NUMBER: A27184. MANUFACTURE DATE: 2012-05. EXPIRATION DATE: 2015-05. 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: 31-JAN-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 (B)(6) 2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("ESSURE DEVICES BROKEN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. A27184) 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) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014 SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), AMNESIA ("MEMORY LOSS"), DYSPAREUNIA ("PAINFUL SEXUAL RELATIONS"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), DYSPNOEA ("SHORTNESS OF BREATH"), ARTHRALGIA ("JOINT PAIN") AND ABDOMINAL PAIN UPPER ("STOMACH PAIN ON THE LOWER LEFT SIDE OF THE ABDOMEN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE WAS REMOVED ON (B)(6) 2023. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DEVICE BREAKAGE, MIGRAINE, AMNESIA, DYSPAREUNIA, INTERMENSTRUAL BLEEDING, WEIGHT INCREASED, DYSPNOEA, ARTHRALGIA OR ABDOMINAL PAIN UPPER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 61 KG. [X-RAY] (DATE UNKNOWN): ESSURE DEVICES BROKEN. 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
    248335 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 A27184 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention