ESSURE
Report
- Report Number
- 2951250-2025-00523
- Event Type
- Injury
- Date Received
- July 31, 2025
- Date of Event
- November 8, 2007
- Report Date
- October 31, 2025
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BAYER CASE NUMBER: (B)(4), EXTREMELY HEAVY FLOW AND BLOOD CLOTS [HEAVY PERIODS] , CRONIC PAIN OVER MY ENTIRE BODY ON A DAY-TO-DAY BASIS [GENERAL BODY PAIN] , HEADACHE [HEADACHE], MENSTRUAL IRREGULARITIES [IRREGULAR MENSTRUATION] , HORRIBLE WEIGHT CHANGES [WEIGHT DECREASE] , BACK INFLAMMATION LOWER BACK , MIDDLE OF NECK [INFLAMMATION LOCALISED] , BLOATING [BLOATING] , SKIN IS SO SENSITIVE TO TOUCH [SENSITIVE SKIN] , INSOMNIA SECONDARY TO ANXIETY [INSOMNIA] , SITUATIONAL ANXIETY [SITUATIONAL ANXIETY] , VAGINITIS [VAGINITIS] , TENSION TYPE HEADACHE [TENSION HEADACHE] , ANXIETY [ANXIETY] , ABNORMAL UTERINE BLEEDING [ABNORMAL UTERINE BLEEDING] , ACUTE URI [ACUTE RESPIRATORY TRACT INFECTION] , ASTHMA, EXERCISE INDUCED [ASTHMA EXERCISE INDUCED] , DERMATITIS [DERMATITIS] , IRON DEFICIENCY ANEMIA [IRON DEFICIENCY ANEMIA], PREDIABETES [PREDIABETES] , SKIN TAG [SKIN TAGS] , HERPES SIMPLEX TYPE 1 [GENITAL HERPES SIMPLEX] , ACUTE SINUSITIS [ACUTE SINUSITIS] , ALLERGIC RHINITIS [ALLERGIC RHINITIS] , DIABETES MELLITUS [DIABETES MELLITUS] , LUMBAGO [LUMBAGO] , DEGENERATION OF LUMBAR INTERVERTEBRAL DISC/DEGENERATION OF ACTIVE INTERMOUNTAIN HEALTH CERVICAL INTERVERTEBRAL DISC [LUMBAR DISC DEGENERATION] , BONE MARROW DISORDER [BONE MARROW DISORDER] , FORAMINAL STENOSIS OF CERVICAL REGION [UTERINE CERVIX STENOSIS] , PALPITATION [PALPITATION] , CHEST PRESSURE [CHEST PRESSURE] , VITAMIN D DEFICIENCY [VITAMIN D DEFICIENCY], TINGLING [TINGLING] , ALLERGIC DRUG REACTION [ALLERGIC REACTION TO DRUG] , MUSCLE SPASM [MUSCLE SPASM] , VITREOUS FLOATERS [VITREOUS FLOATERS] , HYPERTHYROIDISM [HYPERTHYROIDISM] , THYROID FUNCTION TEST ABNORMAL [THYROID FUNCTION TEST ABNORMAL], ALLERGIC RHINITIS [ALLERGIC RHINITIS] , MIGRAINE HEADACHE [MIGRAINE HEADACHE] , CERVICAL RADICULOPATH [CERVICAL RADICULOPATHY] , NECK STRAIN [NECK STRAIN] , STRAIN OF RIGHT TRAPEZIUS MUSCLE [MUSCLE STRAIN] , LUMBAR SPRAIN [LUMBAR SPRAIN] , LUMBAR RADICULOPATHY [LUMBAR RADICULOPATHY] , CONJUNCTIVAL HEMORRHAGE, RIGHT [CONJUNCTIVAL HEMORRHAGE] , FLU-LIKE SYMPTOMS [FLU-LIKE SYMPTOMS] , SORE THROAT [SORE THROAT] , ACUTE RIGHT-SIDED BACK PAIN WITH SCIATICA [SCIATICA] , PERIPHERAL VESTIBULOPATHY [PERIPHERAL VESTIBULAR DISORDER] , SHOULDER STRAIN, RIGHT, INITIAL ENCOUNTER [SHOULDER SPRAIN] , LEFT OTITIS MEDIA [OTITIS MEDIA] , EUSTACHIAN TUBE DYSFUNCTION [EUSTACHIAN TUBE DYSFUNCTION], OBESITY [OBESITY], HYPERTENSION/ELEVATED BLOOD PRESSURE READING [HYPERTENSION] , COUGH [COUGH] , COSTOCHONDRITIS [COSTOCHONDRITIS] , PERIMENOPAUSE [PERIMENOPAUSE] , ACUTE BACTERIAL BRONCHITIS [ACUTE BACTERIAL BRONCHITIS], CHEST TIGHTNESS [CHEST TIGHTNESS] , DIZZINESS [DIZZINESS] , CHEST PAIN [CHEST PAIN] , ANEMIA [ANEMIA] , CERVICAL SPONDYLOSIS [CERVICAL SPONDYLOSIS] , SHOULDER PAIN [SHOULDER PAIN] , HIP PAIN [PAIN IN HIP] , PALPITATION [PALPITATION] , PROTEINURIA [PROTEINURIA], LUMBAR SPONDYLOSIS [LUMBAR SPONDYLOSIS] , LUMBAR HERNIATED DISC [LUMBAR DISC HERNIATION] , PNEUMONIA [PNEUMONIA] . CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("EXTREMELY HEAVY FLOW AND BLOOD CLOTS") IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 2007) 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) 2007, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2007, 28 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PAIN ("CRONIC PAIN OVER MY ENTIRE BODY ON A DAY-TO-DAY BASIS"), HEADACHE ("HEADACHE"), MENSTRUATION IRREGULAR ("MENSTRUAL IRREGULARITIES"), INFLAMMATION ("BACK INFLAMMATION LOWER BACK , MIDDLE OF NECK"), ABDOMINAL DISTENSION ("BLOATING") AND SENSITIVE SKIN (" SKIN IS SO SENSITIVE TO TOUCH") AND WAS FOUND TO HAVE WEIGHT DECREASED ("HORRIBLE WEIGHT CHANGES"). ON UNKNOWN DATE SHE EXPERIENCED INSOMNIA ("INSOMNIA SECONDARY TO ANXIETY"), SITUATIONAL ANXIETY ("SITUATIONAL ANXIETY"), VAGINAL INFECTION ("VAGINITIS"), TENSION HEADACHE ("TENSION TYPE HEADACHE"), ANXIETY ("ANXIETY"), ABNORMAL UTERINE BLEEDING ("ABNORMAL UTERINE BLEEDING"), RESPIRATORY TRACT INFECTION ("ACUTE URI "), ASTHMA EXERCISE INDUCED ("ASTHMA, EXERCISE INDUCED"), DERMATITIS ("DERMATITIS"), IRON DEFICIENCY ANAEMIA ("IRON DEFICIENCY ANEMIA"), GLUCOSE TOLERANCE IMPAIRED ("PREDIABETES"), GENITAL HERPES SIMPLEX ("HERPES SIMPLEX TYPE 1"), ACUTE SINUSITIS ("ACUTE SINUSITIS"), A FIRST EPISODE OF RHINITIS ALLERGIC ("ALLERGIC RHINITIS"), DIABETES MELLITUS ("DIABETES MELLITUS"), BACK PAIN ("LUMBAGO"), INTERVERTEBRAL DISC DEGENERATION ("DEGENERATION OF LUMBAR INTERVERTEBRAL DISC/DEGENERATION OF ACTIVE INTERMOUNTAIN HEALTH CERVICAL INTERVERTEBRAL DISC"), BONE MARROW DISORDER ("BONE MARROW DISORDER"), UTERINE CERVIX STENOSIS ("FORAMINAL STENOSIS OF CERVICAL REGION"), A FIRST EPISODE OF PALPITATIONS ("PALPITATION"), CHEST PRESSURE ("CHEST PRESSURE"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), PARAESTHESIA ("TINGLING"), DRUG HYPERSENSITIVITY ("ALLERGIC DRUG REACTION"), MUSCLE SPASMS ("MUSCLE SPASM"), VITREOUS FLOATERS ("VITREOUS FLOATERS"), HYPERTHYROIDISM ("HYPERTHYROIDISM"), A SECOND EPISODE OF RHINITIS ALLERGIC ("ALLERGIC RHINITIS"), MIGRAINE ("MIGRAINE HEADACHE"), CERVICAL RADICULOPATHY ("CERVICAL RADICULOPATH"), NECK STRAIN ("NECK STRAIN"), MUSCLE STRAIN ("STRAIN OF RIGHT TRAPEZIUS MUSCLE"), LUMBAR SPRAIN ("LUMBAR SPRAIN"), LUMBAR RADICULOPATHY ("LUMBAR RADICULOPATHY"), CONJUNCTIVAL HAEMORRHAGE ("CONJUNCTIVAL HEMORRHAGE, RIGHT"), INFLUENZA LIKE ILLNESS ("FLU-LIKE SYMPTOMS "), OROPHARYNGEAL PAIN ("SORE THROAT"), SCIATICA ("ACUTE RIGHT-SIDED BACK PAIN WITH SCIATICA"), VESTIBULAR DISORDER ("PERIPHERAL VESTIBULOPATHY"), SHOULDER SPRAIN ("SHOULDER STRAIN, RIGHT, INITIAL ENCOUNTER"), OTITIS MEDIA ("LEFT OTITIS MEDIA"), EUSTACHIAN TUBE DYSFUNCTION ("EUSTACHIAN TUBE DYSFUNCTION"), OBESITY ("OBESITY"), HYPERTENSION ("HYPERTENSION/ELEVATED BLOOD PRESSURE READING"), COUGH ("COUGH"), COSTOCHONDRITIS ("COSTOCHONDRITIS"), MENOPAUSE ("PERIMENOPAUSE"), BRONCHITIS BACTERIAL ("ACUTE BACTERIAL BRONCHITIS"), CHEST TIGHTNESS ("CHEST TIGHTNESS"), DIZZINESS ("DIZZINESS"), CHEST PAIN ("CHEST PAIN"), ANAEMIA ("ANEMIA"), CERVICAL SPONDYLOSIS ("CERVICAL SPONDYLOSIS "), SHOULDER PAIN ("SHOULDER PAIN"), PAIN IN HIP ("HIP PAIN"), A SECOND EPISODE OF PALPITATIONS ("PALPITATION"), PROTEINURIA ("PROTEINURIA"), LUMBAR SPONDYLOSIS ("LUMBAR SPONDYLOSIS"), INTERVERTEBRAL DISC PROTRUSION ("LUMBAR HERNIATED DISC") AND PNEUMONIA ("PNEUMONIA") AND WAS FOUND TO HAVE ACROCHORDON ("SKIN TAG") AND THYROID FUNCTION TEST ABNORMAL ("THYROID FUNCTION TEST ABNORMAL"). THE PATIENT WAS TREATED WITH LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM), IRON FORMULA (AMINOBENZOIC ACID, ASCORBIC ACID, CHOLINE, INOSITOL, IRON), FLUTICASONE PROPIONATE, MONTELUKAST SODIUM, VALACYCLOVIR (VALACICLOVIR HYDROCHLORIDE), ACYCLOVIR (ACICLOVIR), HYDROCHLORTHIAZID (HYDROCHLOROTHIAZIDE), AMLODIPINE BESYLATE (AMLODIPINE BESILATE), VENTOLINE (SALBUTAMOL), ERGOCALCIFEROL D2, METHOCARBAMOL AL, DICLOFENACO (DICLOFENAC SODIUM), TOPIRAMATE AND MOUNJARO (TIRZEPATIDE) AS WELL AS SURGERY (SCHEDULE FOR A FULL HYSTERECTOMY IN THE NEXT THIRTY DAYS). AT THE TIME OF THE REPORT, THE GLUCOSE TOLERANCE IMPAIRED, LUMBAR SPRAIN, CONJUNCTIVAL HAEMORRHAGE, OTITIS MEDIA, COSTOCHONDRITIS AND DIZZINESS HAD RESOLVED AND THE HEAVY MENSTRUAL BLEEDING, PAIN, HEADACHE, MENSTRUATION IRREGULAR, WEIGHT DECREASED, INFLAMMATION, ABDOMINAL DISTENSION, SENSITIVE SKIN, INSOMNIA, SITUATIONAL ANXIETY, VAGINAL INFECTION, TENSION HEADACHE, ANXIETY, ABNORMAL UTERINE BLEEDING, RESPIRATORY TRACT INFECTION, ASTHMA EXERCISE INDUCED, DERMATITIS, IRON DEFICIENCY ANAEMIA, ACROCHORDON, GENITAL HERPES SIMPLEX, ACUTE SINUSITIS, LATEST EPISODE OF RHINITIS ALLERGIC, DIABETES MELLITUS, BACK PAIN, INTERVERTEBRAL DISC DEGENERATION, BONE MARROW DISORDER, UTERINE CERVIX STENOSIS, LATEST EPISODE OF PALPITATIONS, CHEST PRESSURE, VITAMIN D DEFICIENCY, DRUG HYPERSENSITIVITY, MUSCLE SPASMS, VITREOUS FLOATERS, HYPERTHYROIDISM, THYROID FUNCTION TEST ABNORMAL, MIGRAINE, CERVICAL RADICULOPATHY, NECK STRAIN, MUSCLE STRAIN, LUMBAR RADICULOPATHY, INFLUENZA LIKE ILLNESS, OROPHARYNGEAL PAIN, SCIATICA, VESTIBULAR DISORDER, SHOULDER SPRAIN, EUSTACHIAN TUBE DYSFUNCTION, OBESITY, HYPERTENSION, COUGH, MENOPAUSE, BRONCHITIS BACTERIAL, CHEST TIGHTNESS, CHEST PAIN, ANAEMIA, CERVICAL SPONDYLOSIS, SHOULDER PAIN, PAIN IN HIP, PROTEINURIA, LUMBAR SPONDYLOSIS, INTERVERTEBRAL DISC PROTRUSION AND PNEUMONIA HAD NOT RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PAIN, HEADACHE, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, WEIGHT DECREASED, INFLAMMATION, ABDOMINAL DISTENSION, SENSITIVE SKIN, INSOMNIA, SITUATIONAL ANXIETY, VAGINAL INFECTION, TENSION HEADACHE, ANXIETY, ABNORMAL UTERINE BLEEDING, RESPIRATORY TRACT INFECTION, ASTHMA EXERCISE INDUCED, DERMATITIS, IRON DEFICIENCY ANAEMIA, GLUCOSE TOLERANCE IMPAIRED, ACROCHORDON, GENITAL HERPES SIMPLEX, ACUTE SINUSITIS, THE FIRST EPISODE OF RHINITIS ALLERGIC, DIABETES MELLITUS, BACK PAIN, INTERVERTEBRAL DISC DEGENERATION, BONE MARROW DISORDER, UTERINE CERVIX STENOSIS, THE FIRST EPISODE OF PALPITATIONS, CHEST PRESSURE, VITAMIN D DEFICIENCY, PARAESTHESIA, DRUG HYPERSENSITIVITY, MUSCLE SPASMS, VITREOUS FLOATERS, HYPERTHYROIDISM, THYROID FUNCTION TEST ABNORMAL, THE SECOND EPISODE OF RHINITIS ALLERGIC, MIGRAINE, CERVICAL RADICULOPATHY, NECK STRAIN, MUSCLE STRAIN, LUMBAR SPRAIN, LUMBAR RADICULOPATHY, CONJUNCTIVAL HAEMORRHAGE, INFLUENZA LIKE ILLNESS, OROPHARYNGEAL PAIN, SCIATICA, VESTIBULAR DISORDER, SHOULDER SPRAIN, OTITIS MEDIA, EUSTACHIAN TUBE DYSFUNCTION, OBESITY, HYPERTENSION, COUGH, COSTOCHONDRITIS, MENOPAUSE, BRONCHITIS BACTERIAL, CHEST TIGHTNESS, DIZZINESS, CHEST PAIN, ANAEMIA, CERVICAL SPONDYLOSIS, SHOULDER PAIN, PAIN IN HIP, THE SECOND EPISODE OF PALPITATIONS, PROTEINURIA, LUMBAR SPONDYLOSIS, INTERVERTEBRAL DISC PROTRUSION OR PNEUMONIA. THE REPORTER COMMENTED: I HAVE EXPERIENCED CHRONIC PAIN OVER MY ENTIRE BODY ON A DAY-TO-DAY BASIS. I LITERALITY HAVE A HEADACHE EVERY SINGLE DAY. MENSTRUAL IRREGULARITIES WITH EXTREMELY HEAVY FLOW AND BLOOD CLOTS. I HAVE HAD HORRIBLE WEIGHT CHANGES IN THE MID-SECTION WITH CONSTANT INFLAMMATION AND BLOATING. MY SKIN IS SO SENSITIVE TO TOUCH. I ACTUALLY STILL HAVE THE DEVICE AND IS SCHEDULE FOR A FULL HYSTERECTOMY IN THE NEXT THIRTY DAYS IT HAS BEEN SEVENTEEN YEARS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 34.696 KG/SQM. [BLOOD PRESSURE MEASUREMENT] ON (B)(6) 2013: 124/81; ON (B)(6) 2015: 142/100; ON (B)(6) 2015: 117/81; ON (B)(6) 2017: 130/86; ON (B)(6) 2017: 142/88; ON (B)(6) 2017: 119/72; ON (B)(6) 2017: 145/89 & 138/84; ON (B)(6) 2017: 128/81; ON (B)(6) 2019: 149/99; ON (B)(6) 2019: 135/84; ON (B)(6) 2019: 136/91; ON (B)(6) 2019: 139/89; ON (B)(6) 2019: 137/91; ON (B)(6) 2020: 148/91; ON (B)(6) 2020: 152/90; ON (B)(6) 2020: 156/96; ON (B)(6) 2020: 148/90; ON (B)(6) 2021: 135/83. [BODY MASS INDEX] (DATE UNKNOWN): (B)(6) 2013 -38.71 , (B)(6) 2015- 38.81 , (B)(6) 2015- 38.24 , (B)(6) 2017 -38.14, (B)(6) 2017 -37.91 , (B)(6) 2017 -38.48 , (B)(6) 2017- 37.5, (B)(6) 2017 -38.3 , (B)(6) 2019- 41.22 , (B)(6) 2019 -41.15 , (B)(6) 2019 -39.51 , (B)(6) 2019- 38.82 , (B)(6) 2020 -38.55. [HEART RATE] ON (B)(6) 2015: 102; (DATE UNKNOWN): 104, [OXYGEN SATURATION] ON 08-JAN-2013: 98; ON (B)(6) 2017: 100; ON (B)(6) 2017: 98; ON (B)(6) 2017: 100; ON (B)(6) 2017: 100; ON (B)(6) 2017: 99; ON (B)(6) 2019: 94; ON (B)(6) 2019: 96; ON (B)(6) 2019: 95; ON (B)(6) 2019: 98; ON (B)(6) 2020: 99. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 21-AUG-2025: NEW EVENTS ABDOMINAL DISTENSION, SENSITIVE SKIN, INSOMNIA, SITUATIONAL ANXIETY, VAGINAL INFECTION, TENSION HEADACHE, ANXIETY, ABNORMAL UTERINE BLEEDING, RESPIRATORY TRACT INFECTION, ASTHMA EXERCISE INDUCED, DERMATITIS, IRON DEFICIENCY ANAEMIA, GLUCOSE TOLERANCE IMPAIRED, ACROCHORDON, GENITAL HERPES SIMPLEX, ACUTE SINUSITIS, RHINITIS ALLERGIC, DIABETES MELLITUS, BACK PAIN, LUMBAR DISC DEGENERATION, CERVICAL DISC DEGENERATION, BONE MARROW DISORDER, UTERINE CERVIX STENOSIS, PALPITATIONS, CHEST PRESSURE, VITAMIN D DEFICIENCY, PARAESTHESIA, DRUG HYPERSENSITIVITY, MUSCLE SPASMS, VITREOUS FLOATERS, HYPERTHYROIDISM, THYROID FUNCTION TEST ABNORMAL, MIGRAINE, CERVICAL RADICULOPATHY, NECK STRAIN, MUSCLE STRAIN, LUMBAR SPRAIN, LUMBAR RADICULOPATHY, CONJUNCTIVAL HAEMORRHAGE, INFLUENZA LIKE ILLNESS, OROPHARYNGEAL PAIN, SCIATICA, VESTIBULAR DISORDER, SHOULDER SPRAIN, OTITIS MEDIA, EUSTACHIAN TUBE DYSFUNCTION, OBESITY, HYPERTENSION, BLOOD PRESSURE INCREASED, COUGH, COSTOCHONDRITIS, MENOPAUSE, BRONCHITIS BACTERIAL, CHEST TIGHTNESS, DIZZINESS, CHEST PAIN, ANAEMIA, CERVICAL SPONDYLOSIS, SHOULDER PAIN, PAIN IN HIP, PROTEINURIA, LUMBAR SPONDYLOSIS, INTERVERTEBRAL DISC PROTRUSION PNEUMONIA ADDED. LAB DATA UPDATED. PATIENTS DATE OF BIRTH ADDED. CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.
BAYER CASE NUMBER: (B)(4) EXTREMELY HEAVY FLOW AND BLOOD CLOTS [HEAVY PERIODS] , CRONIC PAIN OVER MY ENTIRE BODY ON A DAY-TO-DAY BASIS [GENERAL BODY PAIN] , HEADACHE [HEADACHE] , MENSTRUAL IRREGULARITIES [IRREGULAR MENSTRUATION] , HORRIBLE WEIGHT CHANGES [WEIGHT DECREASE] , BACK INFLAMMATION LOWER BACK , MIDDLE OF NECK [INFLAMMATION LOCALISED] , BLOATING [BLOATING] , SKIN IS SO SENSITIVE TO TOUCH [SENSITIVE SKIN] , INSOMNIA SECONDARY TO ANXIETY [INSOMNIA] , SITUATIONAL ANXIETY [SITUATIONAL ANXIETY] , VAGINITIS [VAGINITIS] , TENSION TYPE HEADACHE [TENSION HEADACHE] , ANXIETY [ANXIETY] , ABNORMAL UTERINE BLEEDING [ABNORMAL UTERINE BLEEDING], ACUTE URI [ACUTE RESPIRATORY TRACT INFECTION] , ASTHMA, EXERCISE INDUCED [ASTHMA EXERCISE INDUCED] , DERMATITIS [DERMATITIS] , IRON DEFICIENCY ANEMIA [IRON DEFICIENCY ANEMIA] , PREDIABETES [PREDIABETES] , SKIN TAG [SKIN TAGS] , HERPES SIMPLEX TYPE 1 [GENITAL HERPES SIMPLEX] , ACUTE SINUSITIS [ACUTE SINUSITIS] , ALLERGIC RHINITIS [ALLERGIC RHINITIS] , DIABETES MELLITUS [DIABETES MELLITUS] , LUMBAGO [LUMBAGO] , DEGENERATION OF LUMBAR INTERVERTEBRAL DISC/DEGENERATION OF ACTIVE INTERMOUNTAIN HEALTH CERVICAL INTERVERTEBRAL DISC [LUMBAR DISC DEGENERATION] , BONE MARROW DISORDER [BONE MARROW DISORDER] , FORAMINAL STENOSIS OF CERVICAL REGION [UTERINE CERVIX STENOSIS] , PALPITATION [PALPITATION] , CHEST PRESSURE [CHEST PRESSURE], VITAMIN D DEFICIENCY [VITAMIN D DEFICIENCY] , TINGLING [TINGLING] , ALLERGIC DRUG REACTION [ALLERGIC REACTION TO DRUG] , MUSCLE SPASM [MUSCLE SPASM], VITREOUS FLOATERS [VITREOUS FLOATERS] , HYPERTHYROIDISM [HYPERTHYROIDISM] , THYROID FUNCTION TEST ABNORMAL [THYROID FUNCTION TEST ABNORMAL] , ALLERGIC RHINITIS [ALLERGIC RHINITIS] , MIGRAINE HEADACHE [MIGRAINE HEADACHE] , CERVICAL RADICULOPATH [CERVICAL RADICULOPATHY] , NECK STRAIN [NECK STRAIN] , STRAIN OF RIGHT TRAPEZIUS MUSCLE [MUSCLE STRAIN] , LUMBAR SPRAIN [LUMBAR SPRAIN] , LUMBAR RADICULOPATHY [LUMBAR RADICULOPATHY] , CONJUNCTIVAL HEMORRHAGE, RIGHT [CONJUNCTIVAL HEMORRHAGE] , FLU-LIKE SYMPTOMS [FLU-LIKE SYMPTOMS] , SORE THROAT [SORE THROAT] , ACUTE RIGHT-SIDED BACK PAIN WITH SCIATICA [SCIATICA] , PERIPHERAL VESTIBULOPATHY [PERIPHERAL VESTIBULAR DISORDER] , SHOULDER STRAIN, RIGHT, INITIAL ENCOUNTER [SHOULDER SPRAIN] , LEFT OTITIS MEDIA [OTITIS MEDIA] , EUSTACHIAN TUBE DYSFUNCTION [EUSTACHIAN TUBE DYSFUNCTION] , OBESITY [OBESITY] , HYPERTENSION/ELEVATED BLOOD PRESSURE READING [HYPERTENSION] , COUGH [COUGH] , COSTOCHONDRITIS [COSTOCHONDRITIS] , PERIMENOPAUSE [PERIMENOPAUSE] , ACUTE BACTERIAL BRONCHITIS [ACUTE BACTERIAL BRONCHITIS] , CHEST TIGHTNESS [CHEST TIGHTNESS] , DIZZINESS [DIZZINESS] , CHEST PAIN [CHEST PAIN] , ANEMIA [ANEMIA] , CERVICAL SPONDYLOSIS [CERVICAL SPONDYLOSIS], SHOULDER PAIN [SHOULDER PAIN] , HIP PAIN [PAIN IN HIP] , PALPITATION [PALPITATION] , PROTEINURIA [PROTEINURIA] , LUMBAR SPONDYLOSIS [LUMBAR SPONDYLOSIS] , LUMBAR HERNIATED DISC [LUMBAR DISC HERNIATION] , PNEUMONIA [PNEUMONIA] . CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("EXTREMELY HEAVY FLOW AND BLOOD CLOTS") IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED 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) 2007, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2007, 28 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PAIN ("CRONIC PAIN OVER MY ENTIRE BODY ON A DAY-TO-DAY BASIS"), HEADACHE ("HEADACHE"), MENSTRUATION IRREGULAR ("MENSTRUAL IRREGULARITIES"), INFLAMMATION ("BACK INFLAMMATION LOWER BACK , MIDDLE OF NECK"), ABDOMINAL DISTENSION ("BLOATING") AND SENSITIVE SKIN (" SKIN IS SO SENSITIVE TO TOUCH") AND WAS FOUND TO HAVE WEIGHT DECREASED ("HORRIBLE WEIGHT CHANGES"). ON UNKNOWN DATE SHE EXPERIENCED INSOMNIA ("INSOMNIA SECONDARY TO ANXIETY"), SITUATIONAL ANXIETY ("SITUATIONAL ANXIETY"), VAGINAL INFECTION ("VAGINITIS"), TENSION HEADACHE ("TENSION TYPE HEADACHE"), ANXIETY ("ANXIETY"), ABNORMAL UTERINE BLEEDING ("ABNORMAL UTERINE BLEEDING"), RESPIRATORY TRACT INFECTION ("ACUTE URI "), ASTHMA EXERCISE INDUCED ("ASTHMA, EXERCISE INDUCED"), DERMATITIS ("DERMATITIS"), IRON DEFICIENCY ANAEMIA ("IRON DEFICIENCY ANEMIA"), GLUCOSE TOLERANCE IMPAIRED ("PREDIABETES"), GENITAL HERPES SIMPLEX ("HERPES SIMPLEX TYPE 1"), ACUTE SINUSITIS ("ACUTE SINUSITIS"), A FIRST EPISODE OF RHINITIS ALLERGIC ("ALLERGIC RHINITIS"), DIABETES MELLITUS ("DIABETES MELLITUS"), BACK PAIN ("LUMBAGO"), INTERVERTEBRAL DISC DEGENERATION ("DEGENERATION OF LUMBAR INTERVERTEBRAL DISC/DEGENERATION OF ACTIVE INTERMOUNTAIN HEALTH CERVICAL INTERVERTEBRAL DISC"), BONE MARROW DISORDER ("BONE MARROW DISORDER"), UTERINE CERVIX STENOSIS ("FORAMINAL STENOSIS OF CERVICAL REGION"), A FIRST EPISODE OF PALPITATIONS ("PALPITATION"), CHEST PRESSURE ("CHEST PRESSURE"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"), PARAESTHESIA ("TINGLING"), DRUG HYPERSENSITIVITY ("ALLERGIC DRUG REACTION"), MUSCLE SPASMS ("MUSCLE SPASM"), VITREOUS FLOATERS ("VITREOUS FLOATERS"), HYPERTHYROIDISM ("HYPERTHYROIDISM"), A SECOND EPISODE OF RHINITIS ALLERGIC ("ALLERGIC RHINITIS"), MIGRAINE ("MIGRAINE HEADACHE"), CERVICAL RADICULOPATHY ("CERVICAL RADICULOPATH"), NECK STRAIN ("NECK STRAIN"), MUSCLE STRAIN ("STRAIN OF RIGHT TRAPEZIUS MUSCLE"), LUMBAR SPRAIN ("LUMBAR SPRAIN"), LUMBAR RADICULOPATHY ("LUMBAR RADICULOPATHY"), CONJUNCTIVAL HAEMORRHAGE ("CONJUNCTIVAL HEMORRHAGE, RIGHT"), INFLUENZA LIKE ILLNESS ("FLU-LIKE SYMPTOMS "), OROPHARYNGEAL PAIN ("SORE THROAT"), SCIATICA ("ACUTE RIGHT-SIDED BACK PAIN WITH SCIATICA"), VESTIBULAR DISORDER ("PERIPHERAL VESTIBULOPATHY"), SHOULDER SPRAIN ("SHOULDER STRAIN, RIGHT, INITIAL ENCOUNTER"), OTITIS MEDIA ("LEFT OTITIS MEDIA"), EUSTACHIAN TUBE DYSFUNCTION ("EUSTACHIAN TUBE DYSFUNCTION"), OBESITY ("OBESITY"), HYPERTENSION ("HYPERTENSION/ELEVATED BLOOD PRESSURE READING"), COUGH ("COUGH"), COSTOCHONDRITIS ("COSTOCHONDRITIS"), MENOPAUSE ("PERIMENOPAUSE"), BRONCHITIS BACTERIAL ("ACUTE BACTERIAL BRONCHITIS"), CHEST TIGHTNESS ("CHEST TIGHTNESS"), DIZZINESS ("DIZZINESS"), CHEST PAIN ("CHEST PAIN"), ANAEMIA ("ANEMIA"), CERVICAL SPONDYLOSIS ("CERVICAL SPONDYLOSIS "), SHOULDER PAIN ("SHOULDER PAIN"), PAIN IN HIP ("HIP PAIN"), A SECOND EPISODE OF PALPITATIONS ("PALPITATION"), PROTEINURIA ("PROTEINURIA"), LUMBAR SPONDYLOSIS ("LUMBAR SPONDYLOSIS"), INTERVERTEBRAL DISC PROTRUSION ("LUMBAR HERNIATED DISC") AND PNEUMONIA ("PNEUMONIA") AND WAS FOUND TO HAVE ACROCHORDON ("SKIN TAG") AND THYROID FUNCTION TEST ABNORMAL ("THYROID FUNCTION TEST ABNORMAL"). THE PATIENT WAS TREATED WITH LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM), IRON FORMULA (AMINOBENZOIC ACID, ASCORBIC ACID, CHOLINE, INOSITOL, IRON), FLUTICASONE PROPIONATE, MONTELUKAST SODIUM, VALACYCLOVIR (VALACICLOVIR HYDROCHLORIDE), ACYCLOVIR (ACICLOVIR), HYDROCHLORTHIAZID (HYDROCHLOROTHIAZIDE), AMLODIPINE BESYLATE (AMLODIPINE BESILATE), VENTOLINE (SALBUTAMOL), ERGOCALCIFEROL D2, METHOCARBAMOL AL, DICLOFENACO (DICLOFENAC SODIUM), TOPIRAMATE AND MOUNJARO (TIRZEPATIDE) AS WELL AS SURGERY (SCHEDULE FOR A FULL HYSTERECTOMY IN THE NEXT THIRTY DAYS). AT THE TIME OF THE REPORT, THE GLUCOSE TOLERANCE IMPAIRED, LUMBAR SPRAIN, CONJUNCTIVAL HAEMORRHAGE, OTITIS MEDIA, COSTOCHONDRITIS AND DIZZINESS HAD RESOLVED AND THE HEAVY MENSTRUAL BLEEDING, PAIN, HEADACHE, MENSTRUATION IRREGULAR, WEIGHT DECREASED, INFLAMMATION, ABDOMINAL DISTENSION, SENSITIVE SKIN, INSOMNIA, SITUATIONAL ANXIETY, VAGINAL INFECTION, TENSION HEADACHE, ANXIETY, ABNORMAL UTERINE BLEEDING, RESPIRATORY TRACT INFECTION, ASTHMA EXERCISE INDUCED, DERMATITIS, IRON DEFICIENCY ANAEMIA, ACROCHORDON, GENITAL HERPES SIMPLEX, ACUTE SINUSITIS, LATEST EPISODE OF RHINITIS ALLERGIC, DIABETES MELLITUS, BACK PAIN, INTERVERTEBRAL DISC DEGENERATION, BONE MARROW DISORDER, UTERINE CERVIX STENOSIS, LATEST EPISODE OF PALPITATIONS, CHEST PRESSURE, VITAMIN D DEFICIENCY, DRUG HYPERSENSITIVITY, MUSCLE SPASMS, VITREOUS FLOATERS, HYPERTHYROIDISM, THYROID FUNCTION TEST ABNORMAL, MIGRAINE, CERVICAL RADICULOPATHY, NECK STRAIN, MUSCLE STRAIN, LUMBAR RADICULOPATHY, INFLUENZA LIKE ILLNESS, OROPHARYNGEAL PAIN, SCIATICA, VESTIBULAR DISORDER, SHOULDER SPRAIN, EUSTACHIAN TUBE DYSFUNCTION, OBESITY, HYPERTENSION, COUGH, MENOPAUSE, BRONCHITIS BACTERIAL, CHEST TIGHTNESS, CHEST PAIN, ANAEMIA, CERVICAL SPONDYLOSIS, SHOULDER PAIN, PAIN IN HIP, PROTEINURIA, LUMBAR SPONDYLOSIS, INTERVERTEBRAL DISC PROTRUSION AND PNEUMONIA HAD NOT RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PAIN, HEADACHE, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, WEIGHT DECREASED, INFLAMMATION, ABDOMINAL DISTENSION, SENSITIVE SKIN, INSOMNIA, SITUATIONAL ANXIETY, VAGINAL INFECTION, TENSION HEADACHE, ANXIETY, ABNORMAL UTERINE BLEEDING, RESPIRATORY TRACT INFECTION, ASTHMA EXERCISE INDUCED, DERMATITIS, IRON DEFICIENCY ANAEMIA, GLUCOSE TOLERANCE IMPAIRED, ACROCHORDON, GENITAL HERPES SIMPLEX, ACUTE SINUSITIS, THE FIRST EPISODE OF RHINITIS ALLERGIC, DIABETES MELLITUS, BACK PAIN, INTERVERTEBRAL DISC DEGENERATION, BONE MARROW DISORDER, UTERINE CERVIX STENOSIS, THE FIRST EPISODE OF PALPITATIONS, CHEST PRESSURE, VITAMIN D DEFICIENCY, PARAESTHESIA, DRUG HYPERSENSITIVITY, MUSCLE SPASMS, VITREOUS FLOATERS, HYPERTHYROIDISM, THYROID FUNCTION TEST ABNORMAL, THE SECOND EPISODE OF RHINITIS ALLERGIC, MIGRAINE, CERVICAL RADICULOPATHY, NECK STRAIN, MUSCLE STRAIN, LUMBAR SPRAIN, LUMBAR RADICULOPATHY, CONJUNCTIVAL HAEMORRHAGE, INFLUENZA LIKE ILLNESS, OROPHARYNGEAL PAIN, SCIATICA, VESTIBULAR DISORDER, SHOULDER SPRAIN, OTITIS MEDIA, EUSTACHIAN TUBE DYSFUNCTION, OBESITY, HYPERTENSION, COUGH, COSTOCHONDRITIS, MENOPAUSE, BRONCHITIS BACTERIAL, CHEST TIGHTNESS, DIZZINESS, CHEST PAIN, ANAEMIA, CERVICAL SPONDYLOSIS, SHOULDER PAIN, PAIN IN HIP, THE SECOND EPISODE OF PALPITATIONS, PROTEINURIA, LUMBAR SPONDYLOSIS, INTERVERTEBRAL DISC PROTRUSION OR PNEUMONIA. THE REPORTER COMMENTED: I HAVE EXPERIENCED CHRONIC PAIN OVER MY ENTIRE BODY ON A DAY-TO-DAY BASIS. I LITERALITY HAVE A HEADACHE EVERY SINGLE DAY. MENSTRUAL IRREGULARITIES WITH EXTREMELY HEAVY FLOW AND BLOOD CLOTS. I HAVE HAD HORRIBLE WEIGHT CHANGES IN THE MID-SECTION WITH CONSTANT INFLAMMATION AND BLOATING. MY SKIN IS SO SENSITIVE TO TOUCH. I ACTUALLY STILL HAVE THE DEVICE AND IS SCHEDULE FOR A FULL HYSTERECTOMY IN THE NEXT THIRTY DAYS IT HAS BEEN SEVENTEEN YEARS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 34.696 KG/SQM. [BLOOD PRESSURE MEASUREMENT] ON (B)(6) 2013: 124/81; ON (B)(6) 2015: 142/100; ON (B)(6) 2015: 117/81; ON (B)(6) 2017: 130/86; ON (B)(6) 2017: 142/88; ON (B)(6) 2017: 119/72; ON (B)(6) 2017: 145/89 & 138/84; ON (B)(6) 2017: 128/81; ON (B)(6) 2019: 149/99; ON (B)(6) 2019: 135/84; ON (B)(6) 2019: 136/91; ON (B)(6) 2019: 139/89; ON (B)(6) 2019: 137/91; ON (B)(6) 2020: 148/91; ON (B)(6) 2020: 152/90; ON (B)(6) 2020: 156/96; ON (B)(6) 2020: 148/90; ON (B)(6) 2021: 135/83. [BODY MASS INDEX] (DATE UNKNOWN): (B)(6) 2013 -38.71, (B)(6) 2015- 38.81 , (B)(6) 2015- 38.24 , (B)(6) 2017 -38.14 , (B)(6) 2017 -37.91 , (B)(6) 2017 -38.48 , (B)(6) 2017- 37.5 , (B)(6) 2017 -38.3 , (B)(6) 2019- 41.22 , (B)(6) 2019 -41.15, (B)(6) 2019 -39.51 , (B)(6) 2019- 38.82 , (B)(6) 2020 -38.55. [HEART RATE] ON (B)(6) 2015: 102; (DATE UNKNOWN): 104 [OXYGEN SATURATION] ON (B)(6) 2013: 98; ON (B)(6) 2017: 100; ON (B)(6) 2017: 98; ON (B)(6) 2017: 100; ON (B)(6) 2017: 100; ON (B)(6) 2017: 99; ON (B)(6) 2019: 94; ON (B)(6) 2019: 96; ON (B)(6) 2019: 95; ON (B)(6) 2019: 98; ON (B)(6) 2020: 99. ACCORDING TO BAYER QA, THE LOT NUMBER 2007 IS NOT VALID. 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: 30-OCT-2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: A NOT VALID LOT NUMBER WAS RECEIVED IN THIS CASE. 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. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.
BAYER CASE NUMBER: (B)(4). EXTREMELY HEAVY FLOW AND BLOOD CLOTS [HEAVY PERIODS]. CHRONIC PAIN OVER MY ENTIRE BODY ON A DAY-TO-DAY BASIS [GENERAL BODY PAIN]. HEADACHE [HEADACHE]. MENSTRUAL IRREGULARITIES [IRREGULAR MENSTRUATION]. HORRIBLE WEIGHT CHANGES [WEIGHT DECREASE]. CONSTANT INFLAMMATION [INFLAMMATION]. BLOATING [BLOATING]. SKIN IS SO SENSITIVE TO TOUCH [SENSITIVE SKIN]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("EXTREMELY HEAVY FLOW AND BLOOD CLOTS") IN A 47 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 2007) 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) 2007, THE PATIENT HAD ESSURE INSERTED. ON(B)(6) 2007, 28 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PAIN ("CHRONIC PAIN OVER MY ENTIRE BODY ON A DAY-TO-DAY BASIS"), HEADACHE ("HEADACHE"), MENSTRUATION IRREGULAR ("MENSTRUAL IRREGULARITIES"), INFLAMMATION ("CONSTANT INFLAMMATION"), ABDOMINAL DISTENSION ("BLOATING") AND SENSITIVE SKIN (" SKIN IS SO SENSITIVE TO TOUCH") AND WAS FOUND TO HAVE WEIGHT DECREASED ("HORRIBLE WEIGHT CHANGES "). THE PATIENT WAS TREATED WITH SURGERY (SCHEDULE FOR A FULL HYSTERECTOMY IN THE NEXT THIRTY DAYS). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PAIN, HEADACHE, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, WEIGHT DECREASED, INFLAMMATION, ABDOMINAL DISTENSION OR SENSITIVE SKIN. THE REPORTER COMMENTED: I HAVE EXPERIENCED CHRONIC PAIN OVER MY ENTIRE BODY ON A DAY-TO-DAY BASIS. I LITERALITY HAVE A HEADACHE EVERY SINGLE DAY. MENSTRUAL IRREGULARITIES WITH EXTREMELY HEAVY FLOW AND BLOOD CLOTS. I HAVE HAD HORRIBLE WEIGHT CHANGES IN THE MID-SECTION WITH CONSTANT INFLAMMATION AND BLOATING. MY SKIN IS SO SENSITIVE TO TOUCH. MY BODY FEELS LIKE A SEVENTY-YEAR-OLD. I ACTUALLY STILL HAVE THE DEVICE AND IS SCHEDULE FOR A FULL HYSTERECTOMY IN THE NEXT THIRTY DAYS IT HAS BEEN SEVENTEEN YEARS. CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213350 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 2007 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Female | Required Intervention |