BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 14135029 · Received April 18, 2022

    Report

    Report Number
    2951250-2022-00405
    Event Type
    Injury
    Date Received
    April 18, 2022
    Date of Event
    June 1, 2016
    Report Date
    April 27, 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 12-APR-2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 27-APR-2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF VULVOVAGINAL PAIN ("SEVERE AND DISABLING VULVO-VAGINAL PAIN") IN A 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 61 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED VULVOVAGINAL PAIN (SERIOUSNESS CRITERIA DISABILITY AND MEDICALLY IMPORTANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ALOPECIA ("HAIR LOSS"), DEPRESSED MOOD ("SADNESS") AND FATIGUE ("VERY GREAT FATIGUE"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO VULVOVAGINAL PAIN, ABDOMINAL PAIN, ALOPECIA, DEPRESSED MOOD OR FATIGUE. THE REPORTER COMMENTED: A PLANNED REMOVAL BECAUSE THE SYMPTOMS ARE INCREASING VERY SHARPLY ACTIONS TAKEN IN THE CARE ESTABLISHMENT FOR THE MANAGEMENT OF THE PATIENT: NOT SPECIFIED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 58 KG. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 27-APR-2022: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 VULVOVAGINAL PAIN "SEVERE AND DISABLING VULVO-VAGINAL PAIN" IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 61 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED VULVOVAGINAL PAIN SERIOUSNESS CRITERIA DISABILITY AND MEDICALLY IMPORTANT, ABDOMINAL PAIN "ABDOMINAL PAIN," ALOPECIA "HAIR LOSS," DEPRESSED MOOD "SADNESS" AND FATIGUE "VERY GREAT FATIGUE." ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO VULVOVAGINAL PAIN, ABDOMINAL PAIN, ALOPECIA, DEPRESSED MOOD OR FATIGUE. THE REPORTER COMMENTED: A PLANNED REMOVAL BECAUSE THE SYMPTOMS ARE INCREASING VERY SHARPLY ACTIONS TAKEN IN THE CARE ESTABLISHMENT FOR THE MANAGEMENT OF THE PATIENT: NOT SPECIFIED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE (B)(6) KG. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2641050 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other| S