ESSURE
Report
- Report Number
- 2951250-2022-00173
- Event Type
- Death
- Date Received
- March 2, 2022
- Report Date
- July 21, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE ABDOMINAL PELVIC PAIN ON THE RIGHT SIDE OF THE BODY TOWARDS THE TUBES"), FATAL SQUAMOUS CELL CARCINOMA OF THE CERVIX ("CERVICAL CANCER / MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA"), FATAL ASPIRATION ("BRONCHOASPIRATION") AND FATAL SHOCK ("UNSPECIFIED SHOCK") IN A 24 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. B02267). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF RHINITIS, SMOKER, BRONCHITIS, PARITY 2 AND GRAVIDA II. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MICROVLAR. THE PATIENT HAD A FAMILY HISTORY OF MENTAL DISABILITY (DAUGHTER). THE ONLY CONCOMITANT PRODUCT MENTIONED WAS MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 51 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PROCEDURAL PAIN ("ESSURE PLACEMENT PROCEDURE WAS PAINFUL"). ON (B)(6) 2020 SHE WAS FOUND TO HAVE UTERINE LEIOMYOMA ("LEIOMYOMA"). ON (B)(6) 2021 SHE EXPERIENCED VAGINAL HAEMORRHAGE ("TRANSVAGINAL BLEEDING WITH COAGULA AFTER ESSURE REMOVAL"). ON (B)(6) 2021 SHE EXPERIENCED ABDOMINAL PAIN LOWER ("COLIC") AND OEDEMA PERIPHERAL ("OEDEMA LOWER LIMBS UNTIL KNEES"). ON (B)(6) 2021 SHE WAS FOUND TO HAVE SQUAMOUS CELL CARCINOMA OF THE CERVIX (SERIOUSNESS CRITERION DEATH). ON (B)(6) 2021 SHE EXPERIENCED HYPERTENSION ("HIGH BLOOD PRESSURE"). IN (B)(6) 2023 SHE EXPERIENCED ASPIRATION (SERIOUSNESS CRITERION DEATH) AND SHOCK (SERIOUSNESS CRITERION DEATH). AN UNKNOWN TIME SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BACK PAIN ("PAIN IN THE LOWER BACK THAT RADIATING TO THE LEGS"), GAIT DISTURBANCE ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), HYPOAESTHESIA ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), MUSCULAR WEAKNESS ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), DECREASED APPETITE ("ABSENCE OF APPETITE"), DYSGEUSIA ("TASTE OF METAL IN THE MOUTH"), NAUSEA ("NAUSEA FOLLOWED BY VOMITING"), VOMITING ("NAUSEA FOLLOWED BY VOMITING"), HEADACHE ("SEVERE HEADACHES"), BALANCE DISORDER ("LOSING HIS BALANCE"), GENITAL HAEMORRHAGE ("GENITAL HAEMORRHAGE RECURRENT"), FALL ("FALLING"), LOSS OF LIBIDO ("SEXUAL DISINTEREST") AND ANHEDONIA ("DISINTEREST IN LIVING"). THE PATIENT WAS TREATED WITH DIAZEPAM AND IBUPROFENO AS WELL AS SURGERY (ESSURE REMOVAL VIA BILATERAL SALPINGECTOMY ON (B)(6) 2021). THE PATIENT DIED ON (B)(6) 2023 AND THE REPORTED CAUSES OF DEATH WERE SQUAMOUS CELL CARCINOMA OF THE CERVIX, PULMONARY ASPIRATION, SHOCK, UNSPECIFIED AND METASTATIC UTERINE CANCER. BY THE TIME OF DEATH, THE GENITAL HAEMORRHAGE HAD NOT RESOLVED. THE OUTCOMES FOR PROCEDURAL PAIN, BACK PAIN, GAIT DISTURBANCE, HYPOAESTHESIA, MUSCULAR WEAKNESS, DECREASED APPETITE, DYSGEUSIA, NAUSEA, VOMITING, HEADACHE, BALANCE DISORDER, FALL, HYPERTENSION, LOSS OF LIBIDO, ANHEDONIA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, OEDEMA PERIPHERAL AND UTERINE LEIOMYOMA WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANHEDONIA, ASPIRATION, BACK PAIN, BALANCE DISORDER, DECREASED APPETITE, DYSGEUSIA, FALL, GAIT DISTURBANCE, GENITAL HAEMORRHAGE, HEADACHE, HYPERTENSION, HYPOAESTHESIA, LOSS OF LIBIDO, MUSCULAR WEAKNESS, NAUSEA, OEDEMA PERIPHERAL, PELVIC PAIN, PROCEDURAL PAIN, SHOCK, SQUAMOUS CELL CARCINOMA OF THE CERVIX, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE AND VOMITING TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ESSURE PLACEMENT 5 COILS IN THE LEFT TUBE AND 5 COILS IN THE RIGHT TUBE. ESSURE INSERTION DATE UPDATED FROM (B)(6) 2015 TO (B)(6) 2015. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD GLUCOSE] ON (B)(6) 2021: 87 [BLOOD PRESSURE MEASUREMENT] ON (B)(6) 2015: 110X70 MMHG AND 110X70 MMHG; ON (B)(6) 2021: 113X78 MMHG [BODY TEMPERATURE] ON 22-JUL-2015: 36.4 DEGREES CELSIUS AND 36.1 DEGREES CELSIUS; ON (B)(6)2021: 36.4 DEGREES CELSIUS [HAEMATOCRIT] ON (B)(6) 2021: 33.0 [HAEMOGLOBIN] ON (B)(6) 2021: 11.6 [HEART RATE] ON (B)(6) 2015: 54 HEART BEATS PER MINUTE AND 86 HEART BEATS PER MINUTE; ON (B)(6) 2021: 78 HEART BEATS PER MINUTE [HEPATITIS B VIRUS TEST] ON (B)(6) 2021: NEGATIVE [HEPATITIS C VIRUS TEST] ON (B)(6)V 2021: NEGATIVE [HIV TEST] ON (B)(6) 2021: NEGATIVE [PATHOLOGY TEST] ON (B)(6) -2021: ANATOMOPATHOLOGICAL EXAMINATION OF THE UTERINE CERVIX - MASCROSCOPIC: CONSISTS OF MULTIPLE IRREGULAR FRAGMENTS MEASURING TOGETHER 1.2X0.8X0.4 CM, CONSISTING OF BROWNISH AND ELASTIC TISSUE. MICROSCOPIC: THE HISTOLOGICAL SECTIONS SHOW AN INFILTRATIVE EPITHELIAL NEOPLASM CONSTITUTED BY BLOCKS OF ATYPICAL CELLS, SOME KERATINIZED. MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA [PLATELET COUNT] ON (B)(6) 2021: 205.000 [RED BLOOD CELL COUNT] ON (B)(6) 2021: 3.86 [RESPIRATORY RATE] ON (B)(6) 2015: 18 BREATHS PER MINUTE AND 18 BREATHS PER MINUTE; ON (B)(6) 2021: 18 BREATHS PER MINUTE [ULTRASOUND ABDOMEN] ON (B)(6) 2020: LEFT KIDNEY WITH A SMALL CORTICAL CYST IN THE MIDDLE THIRD, MEASURING 25 MM [ULTRASOUND SCAN VAGINA] ON (B)(6) 2017: ESSURE NORMOPOSITIONED; ON (B)(6) 2020: UTERUS IN AVERSE-FLEXION, WITH NORMAL DIMENSIONS, IRREGULAR CONTOUR AND FINELY HETEROGENEOUS TEXTURE DUE TO THE PRESENCE OF A SOLID NODULE IN THE SUB SEROUS POSTERIOR WALL MEASURING 26X17 MM WHOSE DIAGNOSIS INCLUDES LEIOMYOMA. UTERUS MEASUREMENTS 68X41X52 MM, VOLUME 76 CM3. CENTERED ENDOMETRIUM, MEASURING 10 MM THICK. OVARIES OF NORMAL SHAPE, VOLUME AND TEXTURE, RIGHT OVARY MEASURING 29 X 19 MM, LEFT OVARY MEASURING 28 X 22 MM. PRESENCE OF BILATERALLY IMPLANTED ESSURE DEVICE. THERE IS NO EVIDENCE OF FREE FLUID IN THE POSTERIOR CUL-DE-SAC. LOT NUMBER:B02267 MANUFACTURE DATE: 2013-02 EXPIRATION DATE: 2016-02. 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: 17-APR-2023: FOLLOW UP WAS RECEIVED VIA LAWYER: DEATH CERTIFICATE WAS PROVIDED FOR PLAINTIFF'S DEATH ON (B)(6) 2023 WHICH STATED METASTATIC UTERINE CARCINOMA, BRONCHOASPIRATION, UNSPECIFIED SHOCK AS CAUSE OF DEATH (EVENTS ADDED). REPORTERS ADDED: MOTHER AND DAUGHTER OF PLAINTIFF. WE RECEIVED A LOT NUMBER 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.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE ABDOMINAL PELVIC PAIN ON THE RIGHT SIDE OF THE BODY TOWARDS THE TUBES"), FATAL SQUAMOUS CELL CARCINOMA OF THE CERVIX ("CERVICAL CANCER / MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA"), FATAL ASPIRATION ("BRONCHOASPIRATION") AND FATAL SHOCK ("UNSPECIFIED SHOCK") IN A 24 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. B02267). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF RHINITIS, SMOKER, BRONCHITIS, PARITY 2 AND GRAVIDA II. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MICROVLAR. THE PATIENT HAD A FAMILY HISTORY OF MENTAL DISABILITY (DAUGHTER). THE ONLY CONCOMITANT PRODUCT MENTIONED WAS MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 51 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PROCEDURAL PAIN ("ESSURE PLACEMENT PROCEDURE WAS PAINFUL"). ON (B)(6) 2020 SHE WAS FOUND TO HAVE UTERINE LEIOMYOMA ("LEIOMYOMA"). ON (B)(6) 2021 SHE EXPERIENCED VAGINAL HAEMORRHAGE ("TRANSVAGINAL BLEEDING WITH COAGULA AFTER ESSURE REMOVAL "). ON (B)(6) 2021 SHE EXPERIENCED ABDOMINAL PAIN LOWER ("COLIC") AND OEDEMA PERIPHERAL ("OEDEMA LOWER LIMBS UNTIL KNEES"). ON (B)(6) 2021 SHE WAS FOUND TO HAVE SQUAMOUS CELL CARCINOMA OF THE CERVIX (SERIOUSNESS CRITERION DEATH). ON (B)(6) 2021 SHE EXPERIENCED HYPERTENSION ("HIGH BLOOD PRESSURE"). IN MARCH 2023 SHE EXPERIENCED ASPIRATION (SERIOUSNESS CRITERION DEATH) AND SHOCK (SERIOUSNESS CRITERION DEATH). AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BACK PAIN ("PAIN IN THE LOWER BACK THAT RADIATING TO THE LEGS"), GAIT DISTURBANCE ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), HYPOAESTHESIA ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), MUSCULAR WEAKNESS ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), DECREASED APPETITE ("ABSENCE OF APPETITE"), DYSGEUSIA ("TASTE OF METAL IN THE MOUTH"), NAUSEA ("NAUSEA FOLLOWED BY VOMITING"), VOMITING ("NAUSEA FOLLOWED BY VOMITING"), HEADACHE ("SEVERE HEADACHES"), BALANCE DISORDER ("LOSING HIS BALANCE"), GENITAL HAEMORRHAGE ("GENITAL HAEMORRHAGE RECURRENT"), FALL ("FALLING"), LOSS OF LIBIDO ("SEXUAL DISINTEREST") AND ANHEDONIA ("DISINTEREST IN LIVING"). THE PATIENT WAS TREATED WITH DIAZEPAM AND IBUPROFENO AS WELL AS SURGERY (ESSURE REMOVAL VIA BILATERAL SALPINGECTOMY ON (B)(6) 2021). THE PATIENT DIED ON (B)(6) 2023 AND THE REPORTED CAUSES OF DEATH WERE SQUAMOUS CELL CARCINOMA OF THE CERVIX, PULMONARY ASPIRATION, SHOCK, UNSPECIFIED AND METASTATIC UTERINE CANCER. BY THE TIME OF DEATH, THE GENITAL HAEMORRHAGE HAD NOT RESOLVED. THE OUTCOMES FOR PROCEDURAL PAIN, BACK PAIN, GAIT DISTURBANCE, HYPOAESTHESIA, MUSCULAR WEAKNESS, DECREASED APPETITE, DYSGEUSIA, NAUSEA, VOMITING, HEADACHE, BALANCE DISORDER, FALL, HYPERTENSION, LOSS OF LIBIDO, ANHEDONIA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, OEDEMA PERIPHERAL AND UTERINE LEIOMYOMA WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANHEDONIA, ASPIRATION, BACK PAIN, BALANCE DISORDER, DECREASED APPETITE, DYSGEUSIA, FALL, GAIT DISTURBANCE, GENITAL HAEMORRHAGE, HEADACHE, HYPERTENSION, HYPOAESTHESIA, LOSS OF LIBIDO, MUSCULAR WEAKNESS, NAUSEA, OEDEMA PERIPHERAL, PELVIC PAIN, PROCEDURAL PAIN, SHOCK, SQUAMOUS CELL CARCINOMA OF THE CERVIX, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE AND VOMITING TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ESSURE PLACEMENT 5 COILS IN THE LEFT TUBE AND 5 COILS IN THE RIGHT TUBE. ESSURE INSERTION DATE UPDATED FROM (B)(6) 2015 TO (B)(6) 2015. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD GLUCOSE] ON (B)(6) 2021: 87. [BLOOD PRESSURE MEASUREMENT] ON (B)(6) 2015: 110X70 MMHG AND 110X70 MMHG; ON (B)(6) 2021: 113X78 MMHG. [BODY TEMPERATURE] ON (B)(6) 2015: 36.4 DEGREES CELSIUS AND 36.1 DEGREES CELSIUS; ON (B)(6)2021: 36.4 DEGREES CELSIUS. [HAEMATOCRIT] ON (B)(6) 2021: 33.0. [HAEMOGLOBIN] ON (B)(6) 2021: 11.6. [HEART RATE] ON (B)(6) 2015: 54 HEART BEATS PER MINUTE AND 86 HEART BEATS PER MINUTE; ON (B)(6) 2021: 78 HEART BEATS PER MINUTE. [HEPATITIS B VIRUS TEST] ON (B)(6) 2021: NEGATIVE. [HEPATITIS C VIRUS TEST] ON (B)(6) 2021: NEGATIVE. [HIV TEST] ON (B)(6) 2021: NEGATIVE. [PATHOLOGY TEST] ON (B)(6) 2021: ANATOMOPATHOLOGICAL EXAMINATION OF THE UTERINE CERVIX - MASCROSCOPIC: CONSISTS OF MULTIPLE IRREGULAR FRAGMENTS MEASURING TOGETHER 1.2X0.8X0.4 CM, CONSISTING OF BROWNISH AND ELASTIC TISSUE. MICROSCOPIC: THE HISTOLOGICAL SECTIONS SHOW AN INFILTRATIVE EPITHELIAL NEOPLASM CONSTITUTED BY BLOCKS OF ATYPICAL CELLS, SOME KERATINIZED. MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA. [PLATELET COUNT] ON (B)(6) 2021: 205.000. [RED BLOOD CELL COUNT] ON (B)(6) 2021: 3.86. [RESPIRATORY RATE] ON (B)(6) 2015: 18 BREATHS PER MINUTE AND 18 BREATHS PER MINUTE; ON (B)(6) 2021: 18 BREATHS PER MINUTE. [ULTRASOUND ABDOMEN] ON (B)(6) 2020: LEFT KIDNEY WITH A SMALL CORTICAL CYST IN THE MIDDLE THIRD, MEASURING 25 MM. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2017: ESSURE NORMOPOSITIONED; ON (B)(6) 2020: UTERUS IN AVERSE-FLEXION, WITH NORMAL DIMENSIONS, IRREGULAR CONTOUR AND FINELY HETEROGENEOUS TEXTURE DUE TO THE PRESENCE OF A SOLID NODULE IN THE SUB SEROUS POSTERIOR WALL MEASURING 26X17 MM WHOSE DIAGNOSIS INCLUDES LEIOMYOMA. UTERUS MEASUREMENTS 68X41X52 MM, VOLUME 76 CM3. CENTERED ENDOMETRIUM, MEASURING 10 MM THICK. OVARIES OF NORMAL SHAPE, VOLUME AND TEXTURE, RIGHT OVARY MEASURING 29 X 19 MM, LEFT OVARY MEASURING 28 X 22 MM. PRESENCE OF BILATERALLY IMPLANTED ESSURE DEVICE. THERE IS NO EVIDENCE OF FREE FLUID IN THE POSTERIOR CUL-DE-SAC. LOT NUMBER:B02267 MANUFACTURE DATE: 2013-02 EXPIRATION DATE: 2016-02. 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: 26-APR-2023: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER 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.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE ABDOMINAL PELVIC PAIN ON THE RIGHT SIDE OF THE BODY TOWARDS THE TUBES"), FATAL SQUAMOUS CELL CARCINOMA OF THE CERVIX ("CERVICAL CANCER / MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA// UTERIEN CARCINOMA"), FATAL ASPIRATION ("BRONCHOASPIRATION"), FATAL SHOCK ("UNSPECIFIED SHOCK"), FATAL PANCREATIC CARCINOMA ("PANCREATIC CANCER"), FATAL METASTASES TO LUNG ("LUNG METASTASES"), FATAL UTERINE CANCER ("UTERINE CARCINOMA") AND FATAL METASTASES TO LIVER ("LIVER METASTASES.") IN A 24 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. B02267). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. AN ADDITIONAL SUSPECT PRODUCT WAS VANCOMYCIN. THE PATIENT HAD A MEDICAL HISTORY OF RHINITIS, SMOKER, BRONCHITIS, PARITY 2 AND GRAVIDA II. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MICROVLAR. THE PATIENT HAD A FAMILY HISTORY OF MENTAL DISABILITY (DAUGHTER). CONCURRENT CONDITIONS WERE LISTED AS HYPOTENSION AND CARDIAC ARREST. CONCOMITANT PRODUCTS INCLUDED MEROPENEM AND MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]. ON AN UNKNOWN DATE, THE PATIENT STARTED VANCOMYCIN AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 51 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PROCEDURAL PAIN ("ESSURE PLACEMENT PROCEDURE WAS PAINFUL"). ON (B)(6) 2020 SHE WAS FOUND TO HAVE UTERINE LEIOMYOMA ("LEIOMYOMA"). ON (B)(6) 2021 SHE EXPERIENCED VAGINAL HAEMORRHAGE ("TRANSVAGINAL BLEEDING WITH COAGULA AFTER ESSURE REMOVAL "). ON (B)(6) 2021 SHE EXPERIENCED ABDOMINAL PAIN LOWER ("COLIC") AND OEDEMA PERIPHERAL ("OEDEMA LOWER LIMBS UNTIL KNEES"). ON (B)(6) 2021 SHE WAS FOUND TO HAVE SQUAMOUS CELL CARCINOMA OF THE CERVIX (SERIOUSNESS CRITERION DEATH). ON (B)(6) 2021 SHE EXPERIENCED HYPERTENSION ("HIGH BLOOD PRESSURE"). IN MARCH 2023 SHE EXPERIENCED ASPIRATION (SERIOUSNESS CRITERION DEATH) AND SHOCK (SERIOUSNESS CRITERION DEATH). ON UNKNOWN DATES SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BACK PAIN ("PAIN IN THE LOWER BACK THAT RADIATING TO THE LEGS"), GAIT DISTURBANCE ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), HYPOAESTHESIA ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), MUSCULAR WEAKNESS ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), DECREASED APPETITE ("ABSENCE OF APPETITE"), DYSGEUSIA ("TASTE OF METAL IN THE MOUTH"), NAUSEA ("NAUSEA FOLLOWED BY VOMITING"), VOMITING ("NAUSEA FOLLOWED BY VOMITING"), HEADACHE ("SEVERE HEADACHES"), BALANCE DISORDER ("LOSING HIS BALANCE"), GENITAL HAEMORRHAGE ("GENITAL HAEMORRHAGE RECURRENT"), FALL ("FALLING"), LOSS OF LIBIDO ("SEXUAL DISINTEREST"), ANHEDONIA ("DISINTEREST IN LIVING") AND PAPILLOMA VIRAL INFECTION ("CANCER WHOSE MAIN CAUSE IS HPV") AND WAS FOUND TO HAVE PANCREATIC CARCINOMA (SERIOUSNESS CRITERION DEATH), METASTASES TO LUNG (SERIOUSNESS CRITERION DEATH), UTERINE CANCER (SERIOUSNESS CRITERION DEATH) AND METASTASES TO LIVER (SERIOUSNESS CRITERION DEATH). THE PATIENT WAS TREATED WITH DIAZEPAM AND IBUPROFENO AS WELL AS SURGERY (ESSURE REMOVAL VIA BILATERAL SALPINGECTOMY ON (B)(6) 2021). THE PATIENT DIED ON (B)(6) 2023 AND THE REPORTED CAUSES OF DEATH WERE SQUAMOUS CELL CARCINOMA OF THE CERVIX, PULMONARY ASPIRATION, SHOCK, UNSPECIFIED, METASTATIC UTERINE CANCER, PANCREATIC CARCINOMA, METASTASES TO LUNG AND METASTASES TO LIVER. BY THE TIME OF DEATH, THE GENITAL HAEMORRHAGE HAD NOT RESOLVED. THE OUTCOMES FOR PROCEDURAL PAIN, BACK PAIN, GAIT DISTURBANCE, HYPOAESTHESIA, MUSCULAR WEAKNESS, DECREASED APPETITE, DYSGEUSIA, NAUSEA, VOMITING, HEADACHE, BALANCE DISORDER, FALL, HYPERTENSION, LOSS OF LIBIDO, ANHEDONIA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, OEDEMA PERIPHERAL AND UTERINE LEIOMYOMA WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANHEDONIA, ASPIRATION, BACK PAIN, BALANCE DISORDER, DECREASED APPETITE, DYSGEUSIA, FALL, GAIT DISTURBANCE, GENITAL HAEMORRHAGE, HEADACHE, HYPERTENSION, HYPOAESTHESIA, LOSS OF LIBIDO, METASTASES TO LIVER, METASTASES TO LUNG, MUSCULAR WEAKNESS, NAUSEA, OEDEMA PERIPHERAL, PANCREATIC CARCINOMA, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, PROCEDURAL PAIN, SHOCK, SQUAMOUS CELL CARCINOMA OF THE CERVIX, UTERINE CANCER, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE AND VOMITING TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ESSURE PLACEMENT 5 COILS IN THE LEFT TUBE AND 5 COILS IN THE RIGHT TUBE. ESSURE INSERTION DATE UPDATED FROM (B)(6) 2015. ACCORDING TO THE MEDICAL RECORD, THE PATIENT HAD PANCREATIC CANCER AND CERVICAL CANCER, WITH LIVER AND LUNG METASTASES. (CAUSE OF DEATH DESCRIBED ON THE DEATH CERTIFICATE IS PREVIOUSLY REFERRED METASTATIC UTERINE CARCINOMA). THE CLINICAL PROGRESSION DESCRIBED IN THE CHART SUGGESTS THAT PANCREATIC CANCER (APPARENTLY DIAGNOSED FIRST) AND METASTASES (PULMONARY?) LED TO THE OUTCOME. BOTH PANCREATIC AND CERVICAL CANCER ARE UNRELATED TO ESSURE, ARE COMMON, AND HAVE KNOWN RISK FACTORS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD GLUCOSE] ON (B)(6) 2021: 87. [BLOOD PRESSURE MEASUREMENT] ON (B)(6) 2015: 110X70 MMHG AND 110X70 MMHG; ON (B)(6) 2021: 113X78 MMHG. [BODY TEMPERATURE] ON (B)(6) 2015: 36.4, DEGREES CELSIUS AND 36.1 DEGREES CELSIUS. ON (B)(6) 2021, 36.4 DEGREES CELSIUS. [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): LIVER WITH NORMAL VOLUME, REGULAR CONTOUR AND STEATOTIC DENSITY. MULTIPLE HYPODENSE NODULES, OF VARYING DIAMETERS, SUGGESTING SECONDARY INVOLVEMENT. ABSENCE OF DILATATION OF THE BILE DUCTS. TOPICAL GALLBLADDER. VOLUMINOUS SOLID EXPANSIVE FORMATION, WITH IRREGULAR CONTOURS, LOCATED IN THE PANCREATIC CEPHALIC POLE/FIRST PORTION OF THE DUODENAL ARCH, MEASURING 9.9 X 9.4 CM. NO DEFINED CLEAVAGE PLANES WITH THE COELIAC TRUNK AND SUPERIOR MESENTERIC ARTERY. LYMPHADENOPATHIES SUGGESTIVE OF AORTIC AND MESENTERIC INVOLVEMENT. SPLEEN WITH NORMAL AND HOMOGENEOUS VOLUME. REGULAR ADRENALS. TOPICAL KIDNEYS, OF NORMAL SHAPE AND SIZE. ABSENCE OF DILATATION OF THE PYELOCALICEAL SYSTEMS. ABDOMINAL AORTA WITH USUAL COURSE AND CALIBRE. BLADDER WITH NODULAR PARIETAL THICKENING ON THE FLOOR, WITH A MAXIMUM DIAMETER OF 18 MM. SMALL AMOUNT OF FREE FLUID IN THE PELVIS. [HAEMATOCRIT] ON (B)(6) 2021: 33.0. [HAEMOGLOBIN] ON (B)(6) 2021: 11.6. [HEART RATE] ON (B)(6) 2015: 54 HEART BEATS PER MINUTE AND 86 HEART BEATS PER MINUTE; ON (B)(6) 2021: 78 HEART BEATS PER MINUTE. [HEPATITIS B VIRUS TEST] ON (B)(6) 2021: NEGATIVE. [HEPATITIS C VIRUS TEST] ON (B)(6) 2021: NEGATIVE. [HIV TEST] ON (B)(6) 2021: NEGATIVE. [PATHOLOGY TEST] ON (B)(6) 2021: ANATOMOPATHOLOGICAL EXAMINATION OF THE UTERINE CERVIX - MASCROSCOPIC: CONSISTS OF MULTIPLE IRREGULAR FRAGMENTS MEASURING TOGETHER 1.2X0.8X0.4 CM, CONSISTING OF BROWNISH AND ELASTIC TISSUE. MICROSCOPIC: THE HISTOLOGICAL SECTIONS SHOW AN INFILTRATIVE EPITHELIAL NEOPLASM CONSTITUTED BY BLOCKS OF ATYPICAL CELLS, SOME KERATINIZED. MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA. [PLATELET COUNT] ON (B)(6) 2021: 205.000. [RED BLOOD CELL COUNT] ON (B)(6) 2021: 3.86. [RESPIRATORY RATE] ON (B)(6) 2015: 18 BREATHS PER MINUTE AND 18 BREATHS PER MINUTE; ON (B)(6) 2021: 18 BREATHS PER MINUTE. [ULTRASOUND ABDOMEN] ON (B)(6) 2020: LEFT KIDNEY WITH A SMALL CORTICAL CYST IN THE MIDDLE THIRD, MEASURING 25 MM. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2017: ESSURE NORMOPOSITIONED; ON (B)(6) 2020: UTERUS IN AVERSE-FLEXION, WITH NORMAL DIMENSIONS, IRREGULAR CONTOUR AND FINELY HETEROGENEOUS TEXTURE DUE TO THE PRESENCE OF A SOLID NODULE IN THE SUB SEROUS POSTERIOR WALL MEASURING 26X17 MM WHOSE DIAGNOSIS INCLUDES LEIOMYOMA. UTERUS MEASUREMENTS 68X41X52 MM, VOLUME 76 CM3. CENTERED ENDOMETRIUM, MEASURING 10 MM THICK. OVARIES OF NORMAL SHAPE, VOLUME AND TEXTURE, RIGHT OVARY MEASURING 29 X 19 MM, LEFT OVARY MEASURING 28 X 22 MM. PRESENCE OF BILATERALLY IMPLANTED ESSURE DEVICE. THERE IS NO EVIDENCE OF FREE FLUID IN THE POSTERIOR CUL-DE-SAC. LOT NUMBER: B02267. MANUFACTURE DATE: 2013-02. EXPIRATION DATE: 2016-02. 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: 07-JUL-2023: EVENT UTERINE CARCINOMA, LIVER AND LUNG METASTASES, PANCREATIC CANCER & HPV INFECTION ADDED. REPORTER CAUSALITY COMMENT ADDED. REPORTER ADDED. 07-JUL-2023: MEDICAL RECORD RECEIVED. MEDICAL HISTORY & CONCOMITANT DRUGS ADDED. LAB DATA ADDED. WE RECEIVED A LOT NUMBER 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.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE ABDOMINAL PELVIC PAIN ON THE RIGHT SIDE OF THE BODY TOWARDS THE TUBES"), FATAL SQUAMOUS CELL CARCINOMA OF THE CERVIX ("CERVICAL CANCER / MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA// UTERINE CARCINOMA"), FATAL ASPIRATION ("BRONCHOASPIRATION"), FATAL SHOCK ("UNSPECIFIED SHOCK"), FATAL PANCREATIC CARCINOMA ("PANCREATIC CANCER"), FATAL METASTASES TO LUNG ("LUNG METASTASES"), FATAL UTERINE CANCER ("UTERINE CARCINOMA") AND FATAL METASTASES TO LIVER ("LIVER METASTASES.") IN A 24 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. B02267). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. AN ADDITIONAL SUSPECT PRODUCT WAS VANCOMYCIN. THE PATIENT HAD A MEDICAL HISTORY OF RHINITIS, SMOKER, BRONCHITIS, PARITY 2 AND GRAVIDA II. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MICROVLAR. THE PATIENT HAD A FAMILY HISTORY OF MENTAL DISABILITY (DAUGHTER). CONCURRENT CONDITIONS WERE LISTED AS HYPOTENSION AND CARDIAC ARREST. CONCOMITANT PRODUCTS INCLUDED MEROPENEM AND MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]. ON AN UNKNOWN DATE, THE PATIENT STARTED VANCOMYCIN AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 51 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PROCEDURAL PAIN ("ESSURE PLACEMENT PROCEDURE WAS PAINFUL"). ON (B)(6) 2020 SHE WAS FOUND TO HAVE UTERINE LEIOMYOMA ("LEIOMYOMA"). ON (B)(6) 2021 SHE EXPERIENCED VAGINAL HAEMORRHAGE ("TRANSVAGINAL BLEEDING WITH COAGULA AFTER ESSURE REMOVAL "). ON (B)(6) 2021 SHE EXPERIENCED ABDOMINAL PAIN LOWER ("COLIC") AND OEDEMA PERIPHERAL ("OEDEMA LOWER LIMBS UNTIL KNEES"). ON (B)(6) 2021 SHE WAS FOUND TO HAVE SQUAMOUS CELL CARCINOMA OF THE CERVIX (SERIOUSNESS CRITERION DEATH). ON (B)(6) 2021 SHE EXPERIENCED HYPERTENSION ("HIGH BLOOD PRESSURE"). IN (B)(6) 2023 SHE EXPERIENCED ASPIRATION (SERIOUSNESS CRITERION DEATH) AND SHOCK (SERIOUSNESS CRITERION DEATH). ON UNKNOWN DATES SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BACK PAIN ("PAIN IN THE LOWER BACK THAT RADIATING TO THE LEGS"), GAIT DISTURBANCE ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), HYPOAESTHESIA ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), MUSCULAR WEAKNESS ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), DECREASED APPETITE ("ABSENCE OF APPETITE"), DYSGEUSIA ("TASTE OF METAL IN THE MOUTH"), NAUSEA ("NAUSEA FOLLOWED BY VOMITING"), VOMITING ("NAUSEA FOLLOWED BY VOMITING"), HEADACHE ("SEVERE HEADACHES"), BALANCE DISORDER ("LOSING HIS BALANCE"), GENITAL HAEMORRHAGE ("GENITAL HAEMORRHAGE RECURRENT"), FALL ("FALLING"), LOSS OF LIBIDO ("SEXUAL DISINTEREST"), ANHEDONIA ("DISINTEREST IN LIVING") AND PAPILLOMA VIRAL INFECTION ("CANCER WHOSE MAIN CAUSE IS HPV") AND WAS FOUND TO HAVE PANCREATIC CARCINOMA (SERIOUSNESS CRITERION DEATH), METASTASES TO LUNG (SERIOUSNESS CRITERION DEATH), UTERINE CANCER (SERIOUSNESS CRITERION DEATH) AND METASTASES TO LIVER (SERIOUSNESS CRITERION DEATH). THE PATIENT WAS TREATED WITH DIAZEPAM AND IBUPROFEN AS WELL AS SURGERY (ESSURE REMOVAL VIA BILATERAL SALPINGECTOMY ON (B)(6) 2021). THE PATIENT DIED ON (B)(6) 2023 AND THE REPORTED CAUSES OF DEATH WERE SQUAMOUS CELL CARCINOMA OF THE CERVIX, PULMONARY ASPIRATION, SHOCK, UNSPECIFIED, METASTATIC UTERINE CANCER, PANCREATIC CARCINOMA, METASTASES TO LUNG AND METASTASES TO LIVER. BY THE TIME OF DEATH, THE GENITAL HAEMORRHAGE HAD NOT RESOLVED. THE OUTCOMES FOR PROCEDURAL PAIN, BACK PAIN, GAIT DISTURBANCE, HYPOAESTHESIA, MUSCULAR WEAKNESS, DECREASED APPETITE, DYSGEUSIA, NAUSEA, VOMITING, HEADACHE, BALANCE DISORDER, FALL, HYPERTENSION, LOSS OF LIBIDO, ANHEDONIA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, OEDEMA PERIPHERAL AND UTERINE LEIOMYOMA WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANHEDONIA, ASPIRATION, BACK PAIN, BALANCE DISORDER, DECREASED APPETITE, DYSGEUSIA, FALL, GAIT DISTURBANCE, GENITAL HAEMORRHAGE, HEADACHE, HYPERTENSION, HYPOAESTHESIA, LOSS OF LIBIDO, METASTASES TO LIVER, METASTASES TO LUNG, MUSCULAR WEAKNESS, NAUSEA, OEDEMA PERIPHERAL, PANCREATIC CARCINOMA, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, PROCEDURAL PAIN, SHOCK, SQUAMOUS CELL CARCINOMA OF THE CERVIX, UTERINE CANCER, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE AND VOMITING TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ESSURE PLACEMENT 5 COILS IN THE LEFT TUBE AND 5 COILS IN THE RIGHT TUBE. ESSURE INSERTION DATE UPDATED FROM (B)(6) 2015. ACCORDING TO THE MEDICAL RECORD, THE PATIENT HAD PANCREATIC CANCER AND CERVICAL CANCER, WITH LIVER AND LUNG METASTASES. (CAUSE OF DEATH DESCRIBED ON THE DEATH CERTIFICATE IS PREVIOUSLY REFERRED METASTATIC UTERINE CARCINOMA). THE CLINICAL PROGRESSION DESCRIBED IN THE CHART SUGGESTS THAT PANCREATIC CANCER (APPARENTLY DIAGNOSED FIRST) AND METASTASES (PULMONARY?) LED TO THE OUTCOME. BOTH PANCREATIC AND CERVICAL CANCER ARE UNRELATED TO ESSURE, ARE COMMON, AND HAVE KNOWN RISK FACTORS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD GLUCOSE] ON (B)(6) 2021: 87. [BLOOD PRESSURE MEASUREMENT] ON (B)(6) 2015: 110X70 MMHG AND 110X70 MMHG; ON (B)(6) 2021: 113X78 MMHG. [BODY TEMPERATURE] ON (B)(6) 2015: 36.4 DEGREES CELSIUS AND 36.1 DEGREES CELSIUS; ON (B)(6) 2021: 36.4 DEGREES CELSIUS [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): LIVER WITH NORMAL VOLUME, REGULAR CONTOUR AND STEATOTIC DENSITY. MULTIPLE HYPODENSE NODULES, OF VARYING DIAMETERS, SUGGESTING SECONDARY INVOLVEMENT. ABSENCE OF DILATATION OF THE BILE DUCTS. TOPICAL GALLBLADDER. VOLUMINOUS SOLID EXPANSIVE FORMATION, WITH IRREGULAR CONTOURS, LOCATED IN THE PANCREATIC CEPHALIC POLE/FIRST PORTION OF THE DUODENAL ARCH, MEASURING 9.9 X 9.4 CM. NO DEFINED CLEAVAGE PLANES WITH THE COELIAC TRUNK AND SUPERIOR MESENTERIC ARTERY. LYMPHADENOPATHIES SUGGESTIVE OF AORTIC AND MESENTERIC INVOLVEMENT. SPLEEN WITH NORMAL AND HOMOGENEOUS VOLUME. REGULAR ADRENALS. TOPICAL KIDNEYS, OF NORMAL SHAPE AND SIZE. ABSENCE OF DILATATION OF THE PYELOCALICEAL SYSTEMS. ABDOMINAL AORTA WITH USUAL COURSE AND CALIBRE. BLADDER WITH NODULAR PARIETAL THICKENING ON THE FLOOR, WITH A MAXIMUM DIAMETER OF 18 MM. SMALL AMOUNT OF FREE FLUID IN THE PELVIS. [HAEMATOCRIT] ON (B)(6) 2021: 33.0. [HAEMOGLOBIN] ON (B)(6) 2021: 11.6. [HEART RATE] ON (B)(6) 2015: 54 HEART BEATS PER MINUTE AND 86 HEART BEATS PER MINUTE; ON (B)(6) 2021: 78 HEART BEATS PER MINUTE. [HEPATITIS B VIRUS TEST] ON (B)(6) 2021: NEGATIVE. [HEPATITIS C VIRUS TEST] ON (B)(6) 2021: NEGATIVE. [HIV TEST] ON (B)(6) 2021: NEGATIVE. [PATHOLOGY TEST] ON (B)(6) 2021: ANATOMOPATHOLOGICAL EXAMINATION OF THE UTERINE CERVIX - MACROSCOPIC: CONSISTS OF MULTIPLE IRREGULAR FRAGMENTS MEASURING TOGETHER 1.2X0.8X0.4 CM, CONSISTING OF BROWNISH AND ELASTIC TISSUE. MICROSCOPIC: THE HISTOLOGICAL SECTIONS SHOW AN INFILTRATIVE EPITHELIAL NEOPLASM CONSTITUTED BY BLOCKS OF ATYPICAL CELLS, SOME KERATINIZED. MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA [PLATELET COUNT] ON (B)(6) 2021: 205.000. [RED BLOOD CELL COUNT] ON (B)(6) 2021: 3.86. [RESPIRATORY RATE] ON (B)(6) 2015: 18 BREATHS PER MINUTE AND 18 BREATHS PER MINUTE; ON 1(B)(6) 2021: 18 BREATHS PER MINUTE. [ULTRASOUND ABDOMEN] ON (B)(6) 2020: LEFT KIDNEY WITH A SMALL CORTICAL CYST IN THE MIDDLE THIRD, MEASURING 25 MM. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2017: ESSURE NORMOPOSITIONED; ON (B)(6) 2020: UTERUS IN AVERSE-FLEXION, WITH NORMAL DIMENSIONS, IRREGULAR CONTOUR AND FINELY HETEROGENEOUS TEXTURE DUE TO THE PRESENCE OF A SOLID NODULE IN THE SUB SEROUS POSTERIOR WALL MEASURING 26X17 MM WHOSE DIAGNOSIS INCLUDES LEIOMYOMA. UTERUS MEASUREMENTS 68X41X52 MM, VOLUME 76 CM3. CENTERED ENDOMETRIUM, MEASURING 10 MM THICK. OVARIES OF NORMAL SHAPE, VOLUME AND TEXTURE, RIGHT OVARY MEASURING 29 X 19 MM, LEFT OVARY MEASURING 28 X 22 MM. PRESENCE OF BILATERALLY IMPLANTED ESSURE DEVICE. THERE IS NO EVIDENCE OF FREE FLUID IN THE POSTERIOR CUL-DE-SAC. 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: 20-JUL-2023: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE ABDOMINAL PELVIC PAIN ON THE RIGHT SIDE OF THE BODY TOWARDS THE TUBES') AND SQUAMOUS CELL CARCINOMA OF THE CERVIX ('CERVICAL CANCER /MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B02267) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2, BRONCHITIS, SMOKER AND RHINITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MICROVLAR. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (MEDROXIPROGESTERONA). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("ESSURE PLACEMENT PROCEDURE WAS PAINFUL"). ON (B)(6) 2020, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("LEIOMYOMA"). ON (B)(6) 2021, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("TRANSVAGINAL BLEEDING WITH COAGULA AFTER ESSURE REMOVAL "). ON (B)(6) 2021, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("COLIC") AND OEDEMA PERIPHERAL ("OEDEMA LOWER LIMBS UNTIL KNEES"). ON (B)(6) 2021, THE PATIENT WAS FOUND TO HAVE SQUAMOUS CELL CARCINOMA OF THE CERVIX (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2021, THE PATIENT EXPERIENCED HYPERTENSION ("HIGH BLOOD PRESSURE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BACK PAIN ("PAIN IN THE LOWER BACK THAT RADIATING TO THE LEGS"), GAIT DISTURBANCE ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), HYPOAESTHESIA ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), MUSCULAR WEAKNESS ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), DECREASED APPETITE ("ABSENCE OF APPETITE"), DYSGEUSIA ("TASTE OF METAL IN THE MOUTH"), NAUSEA ("NAUSEA FOLLOWED BY VOMITING"), VOMITING ("NAUSEA FOLLOWED BY VOMITING"), HEADACHE ("SEVERE HEADACHES"), BALANCE DISORDER ("LOSING HIS BALANCE"), GENITAL HAEMORRHAGE ("GENITAL HAEMORRHAGE RECURRENT"), FALL ("FALLING"), LOSS OF LIBIDO ("SEXUAL DISINTEREST") AND ANHEDONIA ("DISINTEREST IN LIVING"). THE PATIENT WAS TREATED WITH DIAZEPAM, IBUPROFEN (IBUPROFENO) AND SURGERY (ESSURE REMOVAL VIA BILATERAL SALPINGECTOMY ON (B)(6) 2021). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PROCEDURAL PAIN, BACK PAIN, GAIT DISTURBANCE, HYPOAESTHESIA, MUSCULAR WEAKNESS, DECREASED APPETITE, DYSGEUSIA, NAUSEA, VOMITING, HEADACHE, BALANCE DISORDER, FALL, HYPERTENSION, SQUAMOUS CELL CARCINOMA OF THE CERVIX, LOSS OF LIBIDO, ANHEDONIA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, OEDEMA PERIPHERAL AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANHEDONIA, BACK PAIN, BALANCE DISORDER, DECREASED APPETITE, DYSGEUSIA, FALL, GAIT DISTURBANCE, GENITAL HAEMORRHAGE, HEADACHE, HYPERTENSION, HYPOAESTHESIA, LOSS OF LIBIDO, MUSCULAR WEAKNESS, NAUSEA, OEDEMA PERIPHERAL, PELVIC PAIN, PROCEDURAL PAIN, SQUAMOUS CELL CARCINOMA OF THE CERVIX, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE AND VOMITING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE PLACEMENT 5 COILS IN THE LEFT TUBE AND 5 COILS IN THE RIGHT TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD GLUCOSE - ON (B)(6) 2021: 87. BLOOD PRESSURE MEASUREMENT - ON (B)(6) 2015: 110X70 MMHG; ON (B)(6) 2015: 110X70 MMHG; ON (B)(6) 2021: 113X78 MMHG. BODY TEMPERATURE (DEGREES CELSIUS) - ON (B)(6) 2015: 36.4 DEGREES CELSIUS; ON (B)(6) 2015: 36.1 DEGREES CELSIUS; ON (B)(6) 2021: 36.4 DEGREES CELSIUS. HIV TEST - ON (B)(6) 2021: NEGATIVE. HAEMATOCRIT - ON (B)(6) 2021: 33.0. HAEMOGLOBIN - ON (B)(6) 2021: 11.6. HEART RATE (HEART BEATS PER MINUTE) - ON (B)(6) 2015: 54 HEART BEATS PER MINUTE; ON (B)(6) 2015: 86 HEART BEATS PER MINUTE; ON (B)(6) 2021: 78 HEART BEATS PER MINUTE. HEPATITIS B VIRUS TEST - ON (B)(6) 2021: NEGATIVE. HEPATITIS C VIRUS TEST - ON (B)(6) 2021: NEGATIVE. PATHOLOGY TEST - ON (B)(6) 2021: ANATOMOPATHOLOGICAL EXAMINATION OF THE UTERINE CERVIX - MASCROSCOPIC: CONSISTS OF MULTIPLE IRREGULAR FRAGMENTS MEASURING TOGETHER 1.2X0.8X0.4 CM, CONSISTING OF BROWNISH AND ELASTIC TISSUE. MICROSCOPIC: THE HISTOLOGICAL SECTIONS SHOW AN INFILTRATIVE EPITHELIAL NEOPLASM CONSTITUTED BY BLOCKS OF ATYPICAL CELLS, SOME KERATINIZED. MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA. PLATELET COUNT - ON (B)(6) 2021: 205.000. RED BLOOD CELL COUNT - ON (B)(6) 2021: 3.86. RESPIRATORY RATE (BREATHS PER MINUTE) - ON (B)(6) 2015: 18 BREATHS PER MINUTE; ON (B)(6) 2015: 18 BREATHS PER MINUTE; ON (B)(6) 2021: 18 BREATHS PER MINUTE. ULTRASOUND ABDOMEN - ON (B)(6) 2020: LEFT KIDNEY WITH A SMALL CORTICAL CYST IN THE MIDDLE THIRD, MEASURING 25 MM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2017: ESSURE NORMOPOSITIONED; ON (B)(6) 2020: UTERUS IN AVERSE-FLEXION, WITH NORMAL DIMENSIONS, IRREGULAR CONTOUR AND FINELY HETEROGENEOUS TEXTURE DUE TO THE PRESENCE OF A SOLID NODULE IN THE SUB SEROUS POSTERIOR WALL MEASURING 26X17 MM WHOSE DIAGNOSIS INCLUDES LEIOMYOMA. UTERUS MEASUREMENTS 68X41X52 MM, VOLUME 76 CM3. CENTERED ENDOMETRIUM, MEASURING 10 MM THICK. OVARIES OF NORMAL SHAPE, VOLUME AND TEXTURE, RIGHT OVARY MEASURING 29 X 19 MM, LEFT OVARY MEASURING 28 X 22 MM. PRESENCE OF BILATERALLY IMPLANTED ESSURE DEVICE. THERE IS NO EVIDENCE OF FREE FLUID IN THE POSTERIOR CUL-DE-SAC.. LOT NUMBER: B02267, MANUFACTURE DATE: 2013-02, AND EXPIRATION DATE: 2016-02. QUALITY-SAFETY EVALUATION OF PTC: 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-MAR-2022: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE ABDOMINAL PELVIC PAIN ON THE RIGHT SIDE OF THE BODY TOWARDS THE TUBES') AND SQUAMOUS CELL CARCINOMA OF THE CERVIX ('CERVICAL CANCER /MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B02267) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2, BRONCHITIS, SMOKER AND RHINITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MICROVLAR. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (MEDROXIPROGESTERONA). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("ESSURE PLACEMENT PROCEDURE WAS PAINFUL"). ON (B)(6) 2020, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("LEIOMYOMA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), BACK PAIN ("PAIN IN THE LOWER BACK THAT RADIATING TO THE LEGS"), GAIT DISTURBANCE ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), HYPOAESTHESIA ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), MUSCULAR WEAKNESS ("DIFFICULTY WALKING DUE TO NUMBNESS AND WEAKNESS IN THE LEGS"), DECREASED APPETITE ("ABSENCE OF APPETITE"), DYSGEUSIA ("TASTE OF METAL IN THE MOUTH"), NAUSEA ("NAUSEA FOLLOWED BY VOMITING"), VOMITING ("NAUSEA FOLLOWED BY VOMITING"), HEADACHE ("SEVERE HEADACHES"), BALANCE DISORDER ("LOSING HIS BALANCE"), GENITAL HAEMORRHAGE ("GENITAL HAEMORRHAGE RECURRENT"), FALL ("FALLING"), LOSS OF LIBIDO ("SEXUAL DISINTEREST") AND ANHEDONIA ("DISINTEREST IN LIVING"). THE PATIENT WAS TREATED WITH DIAZEPAM, IBUPROFEN (IBUPROFENO) AND SURGERY (ESSURE REMOVAL VIA BILATERAL SALPINGECTOMY ON (B)(6) 2021). ESSURE WAS REMOVED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("TRANSVAGINAL BLEEDING WITH COAGULA AFTER ESSURE REMOVAL "). ON (B)(6) 2021, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("COLIC") AND OEDEMA PERIPHERAL ("OEDEMA LOWER LIMBS UNTIL KNEES"). ON (B)(6) 2021, THE PATIENT WAS FOUND TO HAVE SQUAMOUS CELL CARCINOMA OF THE CERVIX (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2021, THE PATIENT EXPERIENCED HYPERTENSION ("HIGH BLOOD PRESSURE"). AT THE TIME OF THE REPORT, THE PELVIC PAIN, PROCEDURAL PAIN, BACK PAIN, GAIT DISTURBANCE, HYPOAESTHESIA, MUSCULAR WEAKNESS, DECREASED APPETITE, DYSGEUSIA, NAUSEA, VOMITING, HEADACHE, BALANCE DISORDER, FALL, HYPERTENSION, SQUAMOUS CELL CARCINOMA OF THE CERVIX, LOSS OF LIBIDO, ANHEDONIA, VAGINAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, OEDEMA PERIPHERAL AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANHEDONIA, BACK PAIN, BALANCE DISORDER, DECREASED APPETITE, DYSGEUSIA, FALL, GAIT DISTURBANCE, GENITAL HAEMORRHAGE, HEADACHE, HYPERTENSION, HYPOAESTHESIA, LOSS OF LIBIDO, MUSCULAR WEAKNESS, NAUSEA, OEDEMA PERIPHERAL, PELVIC PAIN, PROCEDURAL PAIN, SQUAMOUS CELL CARCINOMA OF THE CERVIX, UTERINE LEIOMYOMA, VAGINAL HAEMORRHAGE AND VOMITING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE PLACEMENT 5 COILS IN THE LEFT TUBE AND 5 COILS IN THE RIGHT TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BLOOD GLUCOSE - ON (B)(6) 2021: 87. BLOOD PRESSURE MEASUREMENT - ON (B)(6) 2015: 110X70 MMHG; ON (B)(6) 2015: 110X70 MMHG; ON (B)(6) 2021: 113X78 MMHG. BODY TEMPERATURE (DEGREES CELSIUS) - ON (B)(6) 2015: 36.4 DEGREES CELSIUS; ON (B)(6) 2015: 36.1 DEGREES CELSIUS; ON (B)(6) 2021: 36.4 DEGREES CELSIUS. HIV TEST - ON (B)(6) 2021: (B)(6). HAEMATOCRIT - ON (B)(6) 2021: 33.0. HAEMOGLOBIN - ON (B)(6) 2021: 11.6. HEART RATE (HEART BEATS PER MINUTE) - ON (B)(6) 2015: 54 HEART BEATS PER MINUTE; ON (B)(6) 2015: 86 HEART BEATS PER MINUTE; ON (B)(6) 2021: 78 HEART BEATS PER MINUTE. (B)(6) VIRUS TEST - ON (B)(6) 2021: (B)(6). (B)(6) VIRUS TEST - ON (B)(6) 2021: (B)(6). PATHOLOGY TEST - ON (B)(6) 2021: ANATOMOPATHOLOGICAL EXAMINATION OF THE UTERINE CERVIX - MASCROSCOPIC: CONSISTS OF MULTIPLE IRREGULAR FRAGMENTS MEASURING TOGETHER 1.2X0.8X0.4 CM, CONSISTING OF BROWNISH AND ELASTIC TISSUE. MICROSCOPIC: THE HISTOLOGICAL SECTIONS SHOW AN INFILTRATIVE EPITHELIAL NEOPLASM CONSTITUTED BY BLOCKS OF ATYPICAL CELLS, SOME KERATINIZED. MICROSCOPIC DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA. PLATELET COUNT - ON (B)(6) 2021: 205.000. RED BLOOD CELL COUNT - ON (B)(6) 2021: 3.86. RESPIRATORY RATE (BREATHS PER MINUTE) - ON (B)(6) 2015: 18 BREATHS PER MINUTE; ON (B)(6) 2015: 18 BREATHS PER MINUTE; ON (B)(6) 2021: 18 BREATHS PER MINUTE. ULTRASOUND ABDOMEN - ON (B)(6) 2020: LEFT KIDNEY WITH A SMALL CORTICAL CYST IN THE MIDDLE THIRD, MEASURING 25 MM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2017: ESSURE NORMOPOSITIONED; ON (B)(6) 2020: UTERUS IN AVERSE-FLEXION, WITH NORMAL DIMENSIONS, IRREGULAR CONTOUR AND FINELY HETEROGENEOUS TEXTURE DUE TO THE PRESENCE OF A SOLID NODULE IN THE SUB SEROUS POSTERIOR WALL MEASURING 26X17 MM WHOSE DIAGNOSIS INCLUDES LEIOMYOMA. UTERUS MEASUREMENTS 68X41X52 MM, VOLUME 76 CM3. CENTERED ENDOMETRIUM, MEASURING 10 MM THICK. OVARIES OF NORMAL SHAPE, VOLUME AND TEXTURE, RIGHT OVARY MEASURING 29 X 19 MM, LEFT OVARY MEASURING 28 X 22 MM. PRESENCE OF BILATERALLY IMPLANTED ESSURE DEVICE. THERE IS NO EVIDENCE OF FREE FLUID IN THE POSTERIOR CUL-DE-SAC.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-FEB-2022: THE FOLLOW INFORMATION WERE INCLUDE NEW LAWYER'S REPORTER, PHYSICIAN'S REPORTER, PATIENT'S DETAILS, MEDICAL HISTORY, HISTORICAL DRUG, LAB DATA, OTHER TREATMENT PRODUCTS, CONCOMITANT PRODUCTS, STOP DATE, LOT NUMBER, NEW EVENTS: PROCEDURAL PAIN, LOWER BACK PAIN, NUMBNESS OF LOWER EXTREMITIES, LOWER EXTREMITIES WEAKNESS OF , APPETITE ABSENT, TASTE METALLIC, VOMITING, NAUSEA, HEADACHE, GENITAL BLEEDING,, LOSS OF BALANCE, BLOOD PRESSURE HIGH, GENITAL HAEMORRHAGE, SQUAMOUS CELL CARCINOMA OF THE CERVIX, LACK OF LIBIDO, ANHEDONIA, VAGINAL BLEEDING, LEG EDEMA, LOWER ABDOMINAL PAIN, UTERINE LEIOMYOMA, START DATE UPDATED FROM (B)(6) 2015 TO (B)(6) 2015, ADVERSE REACTION WAS UPDATED TO PELVIC PAIN FEMALE. 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 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 |
|---|---|---|---|---|---|---|---|
| 281408 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B02267 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Female | Required Intervention | MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]| MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]| MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]| MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]| MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]| MEDROXIPROGESTERONA [MEDROXYPROGESTERONE]| MEROPENEM| MEROPENEM |