BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16156208 · Received January 13, 2023

    Report

    Report Number
    2951250-2023-00354
    Event Type
    Injury
    Date Received
    January 13, 2023
    Report Date
    January 26, 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 11-JAN-2023. THE MOST RECENT INFORMATION WAS RECEIVED ON 25-JAN-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925784). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR ("DEVICE VIGILANCE INCIDENT"). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DIZZINESS ("LIGHT-HEADEDNESS"), NAUSEA ("NAUSEA"), LACRIMATION INCREASED ("WATERY"), STRESS ("STRESS"), ERYTHEMA ("REDNESS"), VERTIGO ("VERTIGO"), BLOATING ("BLOATING"), TINNITUS ("TINNITUS"), HEADACHE ("HEADACHES"), SINUSITIS ("SINUSITIS"), DYSPHONIA ("DYSPHONIA"), CONSTIPATION ("CONSTIPATION"), PALPITATIONS ("PALPITATIONS"), HEAVY MENSTRUAL BLEEDING ("HYPERMENORRHEA"), DRY SKIN ("DRY SKIN"), DRY EYE ("DRY EYES"), NASAL DRYNESS ("DRY NOSE"), NECK PAIN ("NECK PAIN"), BACK PAIN ("BACK PAIN"), EYE PRURITUS ("ITCHY EYES"), ARTHRALGIA ("JOINT PAIN"), TENDON PAIN ("TENDON PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), EYE IRRITATION ("BURNING EYES"), HOARSE VOICE ("HOARSE VOICE"), SWOLLEN ABDOMEN ("SWOLLEN BELLY"), ACNE ("WHITE PIMPLES"), VISION BLURRED ("BLURRED VISION"), FATIGUE ("EXTREME FATIGUE"), SLEEP DISORDER ("SLEEP DISORDERS"), MUCOUS STOOLS ("MUCOUS STOOLS"), BALANCE DISORDER ("BALANCE DISORDERS"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MICTURITION DISORDER ("URINATION DISORDERS"), A FIRST EPISODE OF DISTURBANCE IN ATTENTION ("DIFFICULTY FOCUSING"), POLLAKIURIA ("EXCESSIVE URINATION"), MIGRAINE ("CATAMENIAL MIGRAINES"), TRIGEMINAL NEURALGIA ("TRIGEMINAL NEURALGIA"), OROPHARYNGEAL DISCOMFORT ("DISCOMFORT IN THE THROAT"), HYPERSENSITIVITY ("ELECTRICAL HYPERSENSITIVITY"), ALOPECIA ("SEVERE HAIR LOSS"), LIMB DISCOMFORT ("FEELING OF HEAVY LEGS"), CARDIOVASCULAR DISORDER ("POOR BLOOD CIRCULATION"), APHASIA ("DIFFICULTY FINDING WORDS"), BREAST SWELLING ("SWOLLEN AND TENDER BREASTS"), FIBROMYALGIA ("PAIN SIMILAR TO FIBROMYALGIA"), EAR PRURITUS ("ITCHING OF THE AUDITORY CANAL"), NEUROPATHY PERIPHERAL ("INFLAMMATION OF THE PUDENDAL NERVE"), A SECOND EPISODE OF DISTURBANCE IN ATTENTION ("DIFFICULTY CONCENTRATING ON SIMPLE TASKS"), LIGAMENT PAIN ("LIGAMENT PAIN ( UPPER LIMBS , PELVIS , COCCYX )"), A FIRST EPISODE OF BURNING SENSATION ("SUDDENLY FEELING VERY HOT BURNING SENSATIONS IN THE BODY"), DIARRHOEA ("WATERY STOOLS"), ABNORMAL FAECES ("ODOROUS STOOLS"), A SECOND EPISODE OF BURNING SENSATION ("BURNING SENSATIONS"), PAIN IN EXTREMITY ("LIGAMENT PAIN (UPPER LIMBS)"), COCCYDYNIA ("LIGAMENT PAIN (COCCYX PAIN)"), LOSS OF LIBIDO ("LOSS OF LIBIDO") AND BREAST TENDERNESS ("BREAST TENDERNESS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). AT THE TIME OF THE REPORT, THE FATIGUE HAD NOT RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DIZZINESS, NAUSEA, LACRIMATION INCREASED, STRESS, ERYTHEMA, VERTIGO, BLOATING, TINNITUS, HEADACHE, SINUSITIS, DYSPHONIA, CONSTIPATION, PALPITATIONS, HEAVY MENSTRUAL BLEEDING, DRY SKIN, DRY EYE, NASAL DRYNESS, NECK PAIN, BACK PAIN, EYE PRURITUS, ARTHRALGIA, TENDON PAIN, PELVIC PAIN, WEIGHT INCREASED, ABDOMINAL PAIN UPPER, EYE IRRITATION, HOARSE VOICE, SWOLLEN ABDOMEN, ACNE, VISION BLURRED, FATIGUE, SLEEP DISORDER, MUCOUS STOOLS, BALANCE DISORDER, MEMORY IMPAIRMENT, VAGINAL DISCHARGE, MICTURITION DISORDER, THE FIRST EPISODE OF DISTURBANCE IN ATTENTION, POLLAKIURIA, MIGRAINE, TRIGEMINAL NEURALGIA, OROPHARYNGEAL DISCOMFORT, HYPERSENSITIVITY, ALOPECIA, LIMB DISCOMFORT, CARDIOVASCULAR DISORDER, APHASIA, BREAST SWELLING, FIBROMYALGIA, EAR PRURITUS, NEUROPATHY PERIPHERAL, THE SECOND EPISODE OF DISTURBANCE IN ATTENTION, LIGAMENT PAIN, THE FIRST EPISODE OF BURNING SENSATION, DIARRHOEA, ABNORMAL FAECES, THE SECOND EPISODE OF BURNING SENSATION, PAIN IN EXTREMITY, COCCYDYNIA, LOSS OF LIBIDO OR BREAST TENDERNESS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 100 KG. LOT NUMBER: 925784, MANUFACTURE DATE: 2011-11, EXPIRATION DATE: 2014-11. 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: 25-JAN-2023: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMNBER IN THIS CASE. 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 (B)(6) (REFERENCE NUMBER: (B)(4)) ON 11-JAN-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925784). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR ("DEVICE VIGILANCE INCIDENT"). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DIZZINESS ("LIGHT-HEADEDNESS"), NAUSEA ("NAUSEA"), LACRIMATION INCREASED ("WATERY"), STRESS ("STRESS"), ERYTHEMA ("REDNESS"), VERTIGO ("VERTIGO"), BLOATING ("BLOATING"), TINNITUS ("TINNITUS"), HEADACHE ("HEADACHES"), SINUSITIS ("SINUSITIS"), DYSPHONIA ("DYSPHONIA"), CONSTIPATION ("CONSTIPATION"), PALPITATIONS ("PALPITATIONS"), HEAVY MENSTRUAL BLEEDING ("HYPERMENORRHEA"), DRY SKIN ("DRY SKIN"), DRY EYE ("DRY EYES"), NASAL DRYNESS ("DRY NOSE"), NECK PAIN ("NECK PAIN"), BACK PAIN ("BACK PAIN"), EYE PRURITUS ("ITCHY EYES"), ARTHRALGIA ("JOINT PAIN"), TENDON PAIN ("TENDON PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), EYE IRRITATION ("BURNING EYES"), HOARSE VOICE ("HOARSE VOICE"), SWOLLEN ABDOMEN ("SWOLLEN BELLY"), ACNE ("WHITE PIMPLES"), VISION BLURRED ("BLURRED VISION"), FATIGUE ("EXTREME FATIGUE"), SLEEP DISORDER ("SLEEP DISORDERS"), MUCOUS STOOLS ("MUCOUS STOOLS"), BALANCE DISORDER ("BALANCE DISORDERS"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MICTURITION DISORDER ("URINATION DISORDERS"), A FIRST EPISODE OF DISTURBANCE IN ATTENTION ("DIFFICULTY FOCUSING"), POLLAKIURIA ("EXCESSIVE URINATION"), MIGRAINE ("CATAMENIAL MIGRAINES"), TRIGEMINAL NEURALGIA ("TRIGEMINAL NEURALGIA"), OROPHARYNGEAL DISCOMFORT ("DISCOMFORT IN THE THROAT"), HYPERSENSITIVITY ("ELECTRICAL HYPERSENSITIVITY"), ALOPECIA ("SEVERE HAIR LOSS"), LIMB DISCOMFORT ("FEELING OF HEAVY LEGS"), CARDIOVASCULAR DISORDER ("POOR BLOOD CIRCULATION"), APHASIA ("DIFFICULTY FINDING WORDS"), BREAST SWELLING ("SWOLLEN AND TENDER BREASTS"), FIBROMYALGIA ("PAIN SIMILAR TO FIBROMYALGIA"), EAR PRURITUS ("ITCHING OF THE AUDITORY CANAL"), NEUROPATHY PERIPHERAL ("INFLAMMATION OF THE PUDENDAL NERVE"), A SECOND EPISODE OF DISTURBANCE IN ATTENTION ("DIFFICULTY CONCENTRATING ON SIMPLE TASKS"), LIGAMENT PAIN ("LIGAMENT PAIN ( UPPER LIMBS , PELVIS , COCCYX )"), FEELING HOT ("SUDDENLY FEELING VERY HOT BURNING SENSATIONS IN THE BODY"), DIARRHOEA ("WATERY STOOLS"), ABNORMAL FAECES ("ODOROUS STOOLS"), BURNING SENSATION ("BURNING SENSATIONS"), PAIN IN EXTREMITY ("LIGAMENT PAIN (UPPER LIMBS)"), COCCYDYNIA ("LIGAMENT PAIN (COCCYX PAIN)"), LOSS OF LIBIDO ("LOSS OF LIBIDO") AND BREAST TENDERNESS ("BREAST TENDERNESS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). AT THE TIME OF THE REPORT, THE FATIGUE HAD NOT RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DIZZINESS, NAUSEA, LACRIMATION INCREASED, STRESS, ERYTHEMA, VERTIGO, BLOATING, TINNITUS, HEADACHE, SINUSITIS, DYSPHONIA, CONSTIPATION, PALPITATIONS, HEAVY MENSTRUAL BLEEDING, DRY SKIN, DRY EYE, NASAL DRYNESS, NECK PAIN, BACK PAIN, EYE PRURITUS, ARTHRALGIA, TENDON PAIN, PELVIC PAIN, WEIGHT INCREASED, ABDOMINAL PAIN UPPER, EYE IRRITATION, HOARSE VOICE, SWOLLEN ABDOMEN, ACNE, VISION BLURRED, FATIGUE, SLEEP DISORDER, MUCOUS STOOLS, BALANCE DISORDER, MEMORY IMPAIRMENT, VAGINAL DISCHARGE, MICTURITION DISORDER, THE FIRST EPISODE OF DISTURBANCE IN ATTENTION, POLLAKIURIA, MIGRAINE, TRIGEMINAL NEURALGIA, OROPHARYNGEAL DISCOMFORT, HYPERSENSITIVITY, ALOPECIA, LIMB DISCOMFORT, CARDIOVASCULAR DISORDER, APHASIA, BREAST SWELLING, FIBROMYALGIA, EAR PRURITUS, NEUROPATHY PERIPHERAL, THE SECOND EPISODE OF DISTURBANCE IN ATTENTION, LIGAMENT PAIN, FEELING HOT, DIARRHOEA, ABNORMAL FAECES, BURNING SENSATION, PAIN IN EXTREMITY, COCCYDYNIA, LOSS OF LIBIDO OR BREAST TENDERNESS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 100 KG. 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
    1464297 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 925784 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other