BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 18271875 · Received December 5, 2023

    Report

    Report Number
    2951250-2023-03504
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    February 1, 2016
    Report Date
    December 20, 2023
    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) 2023. THE MOST RECENT INFORMATION WAS RECEIVED ON 20-DEC-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("EXCRUCIATING ABDOMINAL PAIN") AND DEVICE DISLOCATION ("EIGHT YEARS AFTER INSERTION ONE IMPLANT DISAPPEARED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED 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) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 99 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), PELVIC PAIN ("FLEETING PAIN LIKE A STAB"), ALOPECIA ("HAIR LOSS"), SLEEP DISORDER ("SLEEP PROBLEMS") AND TOOTH LOSS ("TOOTH LOSS"). AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE . AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ABDOMINAL PAIN, ALOPECIA, SLEEP DISORDER, TOOTH LOSS, PELVIC PAIN OR DEVICE DISLOCATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 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: 20-DEC-2023: 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 01-DEC-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("EXCRUCIATING ABDOMINAL PAIN") AND DEVICE DISLOCATION ("EIGHT YEARS AFTER INSERTION ONE IMPLANT DISAPPEARED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED 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) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 99 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), PELVIC PAIN ("FLEETING PAIN LIKE A STAB"), ALOPECIA ("HAIR LOSS"), SLEEP DISORDER ("SLEEP PROBLEMS") AND TOOTH LOSS ("TOOTH LOSS"). AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE . AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ABDOMINAL PAIN, ALOPECIA, SLEEP DISORDER, TOOTH LOSS, PELVIC PAIN OR DEVICE DISLOCATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 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
    2237077 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other| R