ESSURE
Report
- Report Number
- 2951250-2019-01034
- Event Type
- Injury
- Date Received
- March 6, 2019
- Report Date
- April 9, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("ESSURE COIL COMING OUT OF THE CERVIX/FELL OUT WAS REMOVED"), SALPINGITIS ("BUT THE RIGHT TUBE WAS VERY INFLAMED"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST-IMPLANT PREGNANCY"), GENITAL HAEMORRHAGE ("BLEEDING"), NEUROMYOPATHY ("NEUROMUSCULAR PROBLEMS") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE-LIKE SYMPTOMS") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 830421-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 6 AND TUBAL LIGATION IN 2013. CONCURRENT CONDITIONS INCLUDED UTERINE FIBROID, ANXIETY, DEPRESSION, INSOMNIA, CRAMP IN LOWER ABDOMEN, POST PROCEDURAL BLEEDING, PERIUMBILICAL PAIN, WOUND INFECTION, URETHRAL DISCHARGE NOS, ABDOMINAL WALL WOUND, FASCIAL INFECTION, SOFT TISSUE NECROSIS, NECROSIS NOS, FIBROSIS NOS, INFLAMMATION NOS, POLYCYSTIC OVARIES, PROLONGED PERIODS, IRREGULAR MENSTRUATION, MENSTRUATION FREQUENT, MENOMETRORRHAGIA, LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION, HUMAN PAPILLOMA VIRUS INFECTION, CERVICAL BIOPSY, CHRONIC CERVICITIS, BENIGN CERVICAL TUMOR, PAP SMEAR ABNORMAL, SECONDARY AMENORRHOEA, ANXIETY, BIPOLAR DISORDER, MOOD SWINGS, ABDOMINAL INJURY, VAGINAL DISORDER NOS, BACK PAIN, PAIN IN CERVICAL SPINE, VOMITING, DIZZINESS, DIFFICULTY BREATHING, PANIC ATTACKS, MORBID OBESITY, VAGINAL BLEEDING, HYPERLIPIDEMIA, THYROID DISORDER, GERD, SHORT MENSTRUATION, ARRHYTHMIA (BROTHER), HYPOTHYROIDISM (MOTHER), PREDIABETES, TOOTH PAIN, HYPERHIDROSIS, DIABETES MELLITUS LOSS OF CONTROL, POLYHYDRAMNIOS, LIVER ENLARGEMENT, HEPATIC STEATOSIS, WEAKNESS, HYPERGLYCEMIA, NON-INSULIN-DEPENDENT DIABETES MELLITUS, SNORING, EXHAUSTION, SLEEP WALKING, COMMUNITY ACQUIRED PNEUMONIA, TYPE 2 DIABETES MELLITUS, COUGH, ENDOMETRIAL BIOPSY, HYPERPLASIA ENDOMETRIAL, DYSFUNCTIONAL UTERINE BLEEDING, HEMATURIA AND SCHIZOPHRENIA. THE PATIENT ALSO HAD A FAMILY HISTORY OF ARRHYTHMIA AND HYPOTHYROIDISM. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), ANTIBIOTICS, CEFAZOLIN, CEFDINIR, CEFTRIAXONE SODIUM (ROCEPHIN), DOCUSATE SODIUM, FLUOXETINE HYDROCHLORIDE (PROZAC), GABAPENTIN, GLIBENCLAMIDE (GLYBURIDE), HYDROCODONE;PARACETAMOL (ACETAMINOPHEN;HYDROCODONE), IBUPROFEN, KETOROLAC, LABETALOL, LEVOFLOXACIN (LEVAQUIN), LISINOPRIL, LORAZEPAM (ATIVAN), METFORMIN HYDROCHLORIDE (GLUCOPHAGE), METHYLDOPA, MINERALS NOS;VITAMINS NOS (PRENATAL VITAMINS), MORPHINE, NALBUPHINE, ONDANSETRON HYDROCHLORIDE (ONDANSETRON HCL), QUETIAPINE FUMARATE (SEROQUEL), ROSUVASTATIN CALCIUM (CRESTOR), SIMETICONE (SIMETHICONE), SIMVASTATIN, TROMETAMOL (TROMETHAMINE), ZOLPIDEM AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 3 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NEUROMYOPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISORDER ("VAGINAL SCARRING"), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INFECTION ("INFECTION"), PELVIC PAIN ("PAIN"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2013 FELL OUT, SO THE COIL WAS REMOVED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, SALPINGITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, NEUROMYOPATHY, VAGINAL DISORDER, AUTOIMMUNE DISORDER, INFECTION, PELVIC PAIN, URINARY TRACT DISORDER AND DYSPAREUNIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 6. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE CAESAREAN DELIVERY OCCURRED ON (B)6) 2017. THE APGAR SCORES WERE 9 AND 9 (AT 1 AND 5 MINUTES). THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, DEVICE EXPULSION, DYSPAREUNIA, GENITAL HAEMORRHAGE, INFECTION, NEUROMYOPATHY, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SALPINGITIS, URINARY TRACT DISORDER AND VAGINAL DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RIGHT FALLOPIAN OCCLUSION BUT LEFT FALLOPIAN TUBAL OCCLUSION DEVICE IS NOT SEEN. TUBAL LIGATION ON (B)(6) 2013 AFTER HAVING A FAILURE OF AN ESSURE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2018: 1. UNREMARKABLE APPEARANCE OF THE SLEEVE GASTRECTOMY. NO EXTRA LUMINAL GAS OR FLUID COLLECTION IS SEEN AROUND THE STOMACH. 2. SMALL HIATAL HERNIA. 3. HEPATOMEGALY WITH FATTY INFILTRATION. 4. MILD SPLENOMEGALY. 5. FOCAL ROUND CONSOLIDATION IN THE SUPERIOR SEGMENT OF THE LEFT UPPER LOBE.; ON (B)(6) 2018: 1. UNREMARKABLE APPEARANCE OF SLEEVE GASTRECTOMY. NO EXTRALUMINAL GAS OR FLUID COLLECTION SEEN AROUND THE STOMACH. SMALL HIATAL HERNIA. 2. HEPATOMEGALY WITH FATTY INFILTRATION. 3. MILD SPLENOMEGALY. 4. FOCAL ROUND CONSOLIDATION IN THE SUPERIOR SEGMENT OF THE LEFT UPPER LOBE OF THE LUNGS.. HUMAN PAPILLOMA VIRUS TEST - ON (B)(6) 2013: SEXUALLY TRANSMITTED DISEASES HISTORY IS POSITIVE.. PREGNANCY TEST URINE - ON (B)(6) 2016: RESULT POSITIVE. SPINAL X-RAY - ON (B)(6) 2016: 1. DIFFUSE STRAIGHTENING OF THE CERVICAL SPINE WHICH MAY BE RELATED TO PARA SPINAL MUSCLE SPASM VERSUS POSITIONING; ON (B)(6) 2016: MILD RIGHT CONVEX SCOLIOSIS CENTERED AT T6. ULTRASOUND ABDOMEN - ON (B)(6) 2016: HEPATOMEGALY WITH FATTY INFILTRATION OF THE LIVER. NO EVIDENCE OF GALLSTONES. ULTRASOUND KIDNEY - ON (B)(6) 2016: 1. MILD NONSPECIFIC RIGHT RENAL ENLARGEMENT. NO HYDRO NEPHROSIS. 2. OTHERWISE UNREMARKABLE RENAL ULTRASOUND.; ON (B)(6) 2018: NORMAL RENAL ULTRASOUND. MILDLY INCREASED BLADDER POSTVOID RESIDUAL. ULTRASOUND PELVIS - ON (B)(6) 2013: I. NORMAL UTERUS, 2. ENDOMETRIAL THICKNESS 8 MM. 3.2 X 1.3 CM CYST OF THE LEFT OVARY. THERE IS ALSO A SMALL AMOUNT OF FLUID IN THE CUL-DE-SAC, POSSIBLY ARISING FROM LEAKAGE OF THE OVARIAN CYST.; ON (B)(6) 2013: 1. NORMAL UTERUS, 2. ENDOMETRIAL THICKNESS 1.2 CM. 3. THE RIGHT TUBAL COIL IS SEEN IN THE RIGHT UTERINE CORNU. 2 CM LEFT OVARIAN CORPUS LUTEUM CYST. ULTRASOUND SCAN - ON (B)(6) 2016: 1. BASED ON ULTRASOUND CRITERIA, THE ESTIMATED GESTATIONAL AGE IS APPROXIMATELY 19 WEEKS 5 DAYS, WITH AN ESTIMATED DATE OF DELIVERY OF 03,01,2017. 2. THE ESTIMATED FETAL WEIGHT IS 326 G, 53 %ILE BASED ON ULTRASOUND CRITERIA. 4. THE AFI MEASURES 12.5 CM. 5. NORMAL, LIMITED FETAL ANATOMIC SURVEY. FETAL NOSE AND LIPS WERE NOT WELL VISUALIZED.; ON (B)(6) 2016: 1. SINGLE, LIVE, INTRAUTERINE GESTATION ESTIMATED GESTATIONAL AGE OF 19 WEEKS 6 DAYS BY ULTRASOUND CRITERIA. 2. THE ESTIMATED DATE OF DELIVERY IS (B)(6) 2017.; ON (B)(6) 2016: 1. SINGLE, LIVE, INTRAUTERINE GESTATION. 2. AMNIOTIC FLUID INDEX IS 15.0 CM.; ON (B)(6) 2016: 1. SINGLE, LIVE, INTRAUTERINE GESTATION. 2. AMNIOTIC FLUID INDEX IS 15.0 CM.; ON (B)(6) 2017: 1. SINGLE LIVE INTRAUTERINE GESTATION OF 34 WEEKS 2 DAYS (BASED ON ULTRASOUND MEASUREMENTS), AS ABOVE.; ON (B)(6) 2017: NORMAL BIOPHYSICAL PROFILE; ON (B)(6) 2017: 1. SINGLE VIABLE INTRAUTERINE GESTATION. 2. BIOPHYSICAL PROFILE = 8,8. 3. API = 21.1 CM.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). INCIDENT NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NONCONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("ESSURE COIL COMING OUT OF THE CERVIX/FELL OUT WAS REMOVED"), SALPINGITIS ("BUT THE RIGHT TUBE WAS VERY INFLAMED"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST-IMPLANT PREGNANCY"), GENITAL HAEMORRHAGE ("BLEEDING"), NEUROMYOPATHY ("NEUROMUSCULAR PROBLEMS") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE-LIKE SYMPTOMS") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 830421) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 6 AND TUBAL LIGATION IN 2013. CONCURRENT CONDITIONS INCLUDED UTERINE FIBROID, ANXIETY, DEPRESSION, INSOMNIA, ABDOMINAL PAIN LOWER, POST PROCEDURAL BLEEDING, PERIUMBILICAL PAIN, WOUND INFECTION, URETHRAL DISCHARGE NOS, ABDOMINAL WALL WOUND, FASCIAL INFECTION, SOFT TISSUE NECROSIS, COAGULATION NECROSIS, FIBROSIS NOS, INFLAMMATION NOS, POLYCYSTIC OVARIES, PROLONGED PERIODS, IRREGULAR MENSTRUATION, MENSTRUATION FREQUENT, MENOMETRORRHAGIA, LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION, HUMAN PAPILLOMA VIRUS INFECTION, CERVICAL BIOPSY, CHRONIC CERVICITIS, BENIGN CERVICAL TUMOR, PAP SMEAR ABNORMAL, SECONDARY AMENORRHOEA, ANXIETY, BIPOLAR DISORDER, MOOD SWINGS, ABDOMINAL INJURY, VAGINAL DISORDER NOS, BACK PAIN, PAIN IN CERVICAL SPINE, VOMITING, DIZZINESS, DIFFICULTY BREATHING, PANIC ATTACKS, MORBID OBESITY, VAGINAL BLEEDING, HYPERLIPIDEMIA, THYROID DISORDER, GERD, SHORT MENSTRUATION, ARRHYTHMIA (BROTHER), HYPOTHYROIDISM (MOTHER), PREDIABETES, TOOTH PAIN, HYPERHIDROSIS, DIABETES MELLITUS LOSS OF CONTROL, POLYHYDRAMNIOS, LIVER ENLARGEMENT, HEPATIC STEATOSIS, WEAKNESS, HYPERGLYCEMIA, NON-INSULIN-DEPENDENT DIABETES MELLITUS, SNORING, EXHAUSTION, SLEEP WALKING, COMMUNITY ACQUIRED PNEUMONIA, TYPE 2 DIABETES MELLITUS, COUGH, ENDOMETRIAL BIOPSY, HYPERPLASIA ENDOMETRIAL, DYSFUNCTIONAL UTERINE BLEEDING, HEMATURIA AND SCHIZOPHRENIA. THE PATIENT ALSO HAD A FAMILY HISTORY OF ARRHYTHMIA AND HYPOTHYROIDISM. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), ANTIBIOTICS, CEFAZOLIN, CEFDINIR, CEFTRIAXONE SODIUM (ROCEPHIN), DOCUSATE SODIUM, ENOXAPARIN SODIUM (LOVENOX), FLUOXETINE HYDROCHLORIDE (PROZAC), GABAPENTIN, GLIBENCLAMIDE (GLYBURIDE), HYDROCODONE;PARACETAMOL (ACETAMINOPHEN;HYDROCODONE), IBUPROFEN, KETOROLAC, LABETALOL, LEVOFLOXACIN (LEVAQUIN), LISINOPRIL, LORAZEPAM (ATIVAN), METFORMIN HYDROCHLORIDE (GLUCOPHAGE), METHYLDOPA, MINERALS NOS;VITAMINS NOS (PRENATAL VITAMINS), MORPHINE, NALBUPHINE, ONDANSETRON HYDROCHLORIDE (ONDANSETRON HCL), QUETIAPINE FUMARATE (SEROQUEL), ROSUVASTATIN CALCIUM (CRESTOR), SIMETHICONE (SIMETHICONE), SIMVASTATIN, TROMETAMOL (TROMETHAMINE), ZOLPIDEM AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 3 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NEUROMYOPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SCAR ("VAGINAL SCARRING"), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INFECTION ("INFECTION"), PELVIC PAIN ("PAIN"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2013 FELL OUT, SO THE COIL WAS REMOVED). AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, SALPINGITIS, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, NEUROMYOPATHY, SCAR, AUTOIMMUNE DISORDER, INFECTION, PELVIC PAIN, URINARY TRACT DISORDER AND DYSPAREUNIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 6. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2017. THE APGAR SCORES WERE 9 AND 9 (AT 1 AND 5 MINUTES). THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, DEVICE EXPULSION, DYSPAREUNIA, GENITAL HAEMORRHAGE, INFECTION, NEUROMYOPATHY, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SALPINGITIS, SCAR AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RIGHT FALLOPIAN OCCLUSION BUT LEFT FALLOPIAN TUBAL OCCLUSION DEVICE IS NOT SEEN. TUBAL LIGATION ON (B)(6) 2013 AFTER HAVING A FAILURE OF AN ESSURE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2018: UNREMARKABLE APPEARANCE OF THE SLEEVE GASTRECTOMY. NO EXTRA LUMINAL GAS OR FLUID COLLECTION IS SEEN AROUND THE STOMACH. SMALL HIATAL HERNIA. HEPATOMEGALY WITH FATTY INFILTRATION. MILD SPLENOMEGALY. FOCAL ROUND CONSOLIDATION IN THE SUPERIOR SEGMENT OF THE LEFT UPPER LOBE; ON (B)(6) 2018: UNREMARKABLE APPEARANCE OF SLEEVE GASTRECTOMY. NO EXTRALUMINAL GAS OR FLUID COLLECTION SEEN AROUND THE STOMACH. SMALL HIATAL HERNIA. HEPATOMEGALY WITH FATTY INFILTRATION. MILD SPLENOMEGALY. FOCAL ROUND CONSOLIDATION IN THE SUPERIOR SEGMENT OF THE LEFT UPPER LOBE OF THE LUNGS. (B)(6) TEST - ON (B)(6) 2013: SEXUALLY TRANSMITTED DISEASES HISTORY IS (B)(6). PREGNANCY TEST URINE - ON (B)(6) 2016: RESULT POSITIVE. SPINAL X-RAY - ON (B)(6) 2016: DIFFUSE STRAIGHTENING OF THE CERVICAL SPINE WHICH MAY BE RELATED TO PARA SPINAL MUSCLE SPASM VERSUS POSITIONING; ON (B)(6) 2016: MILD RIGHT CONVEX SCOLIOSIS CENTERED AT T6. ULTRASOUND ABDOMEN - ON (B)(6) 2016: HEPATOMEGALY WITH FATTY INFILTRATION OF THE LIVER. NO EVIDENCE OF GALLSTONES. ULTRASOUND KIDNEY - ON (B)(6) 2016: MILD NONSPECIFIC RIGHT RENAL ENLARGEMENT. NO HYDRO NEPHROSIS. OTHERWISE UNREMARKABLE RENAL ULTRASOUND; ON (B)(6) 2018: NORMAL RENAL ULTRASOUND. MILDLY INCREASED BLADDER POSTVOID RESIDUAL. ULTRASOUND PELVIS - ON (B)(6) 2013: NORMAL UTERUS, ENDOMETRIAL THICKNESS 8 MM. 3.2 X 1.3 CM CYST OF THE LEFT OVARY. THERE IS ALSO A SMALL AMOUNT OF FLUID IN THE CUL-DE-SAC, POSSIBLY ARISING FROM LEAKAGE OF THE OVARIAN CYST; ON (B)(6) 2013: NORMAL UTERUS, ENDOMETRIAL THICKNESS 1.2 CM. THE RIGHT TUBAL COIL IS SEEN IN THE RIGHT UTERINE CORNU. 2 CM LEFT OVARIAN CORPUS LUTEUM CYST. ULTRASOUND SCAN - ON (B)(6) 2016: BASED ON ULTRASOUND CRITERIA, THE ESTIMATED GESTATIONAL AGE IS APPROXIMATELY (B)(6), WITH AN ESTIMATED DATE OF DELIVERY OF (B)(6) 2017. THE ESTIMATED FETAL WEIGHT IS (B)(6) BASED ON ULTRASOUND CRITERIA. THE AFI MEASURES 12.5 CM. 5. NORMAL, LIMITED FETAL ANATOMIC SURVEY. FETAL NOSE AND LIPS WERE NOT WELL VISUALIZED; ON (B)(6) 2016: SINGLE, LIVE, INTRAUTERINE GESTATION ESTIMATED GESTATIONAL AGE OF (B)(6) BY ULTRASOUND CRITERIA. THE ESTIMATED DATE OF DELIVERY IS (B)(6) 2017; ON (B)(6) 2016: SINGLE, LIVE, INTRAUTERINE GESTATION. AMNIOTIC FLUID INDEX IS 15.0 CM; ON (B)(6) 2016: SINGLE, LIVE, INTRAUTERINE GESTATION. AMNIOTIC FLUID INDEX IS 15.0 CM; ON (B)(6) 2017: SINGLE LIVE INTRAUTERINE GESTATION OF (B)(6) (BASED ON ULTRASOUND MEASUREMENTS), AS ABOVE; ON (B)(6) 2017: NORMAL BIOPHYSICAL PROFILE; ON (B)(6) 2017: SINGLE VIABLE INTRAUTERINE GESTATION. BIOPHYSICAL PROFILE = 8,8. API = 21.1 CM. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189181 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 830421-INVALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R | ACETAMINOPHEN,HYDROCODONE| ACETAMINOPHEN,HYDROCODONE| AMBIEN| AMBIEN| ANTIBIOTICS| ANTIBIOTICS| ATIVAN| ATIVAN| CEFAZOLIN| CEFAZOLIN| CEFDINIR| CEFDINIR| CRESTOR| CRESTOR| DOCUSATE SODIUM| DOCUSATE SODIUM| GABAPENTIN| GABAPENTIN| GLUCOPHAGE| GLUCOPHAGE| GLYBURIDE| GLYBURIDE| IBUPROFEN| IBUPROFEN| KETOROLAC| KETOROLAC| LABETALOL| LABETALOL| LEVAQUIN| LEVAQUIN| LISINOPRIL| LISINOPRIL| LOVENOX| METHYLDOPA| METHYLDOPA| MORPHINE| MORPHINE| NALBUPHINE| NALBUPHINE| ONDANSETRON HCL| ONDANSETRON HCL| OTHER THERAPEUTIC PRODUCTS| PRENATAL VITAMINS [MINERALS NOS,VITAMINS NOS]| PRENATAL VITAMINS [MINERALS NOS,VITAMINS NOS]| PROZAC| PROZAC| ROCEPHIN| ROCEPHIN| SEROQUEL| SEROQUEL| SIMETHICONE| SIMETHICONE| SIMVASTATIN| SIMVASTATIN| TROMETHAMINE| TROMETHAMINE| XANAX| XANAX| ZOLPIDEM| ZOLPIDEM| ACETAMINOPHEN,HYDROCODONE| AMBIEN| ANTIBIOTICS| ATIVAN| CEFAZOLIN| CEFDINIR| CRESTOR| DOCUSATE SODIUM| GABAPENTIN| GLUCOPHAGE| GLYBURIDE| IBUPROFEN| KETOROLAC| LABETALOL| LEVAQUIN| LISINOPRIL| LOVENOX| METHYLDOPA| MORPHINE| NALBUPHINE| ONDANSETRON HCL| PRENATAL VITAMINS [MINERALS NOS,VITAMINS NOS]| PROZAC| ROCEPHIN| SEROQUEL| SIMETHICONE| SIMVASTATIN| TROMETHAMINE| XANAX| ZOLPIDEM |