ESSURE
Report
- Report Number
- 2951250-2018-01792
- Event Type
- Injury
- Date Received
- April 13, 2018
- Report Date
- September 27, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN/I WAS HURTING") AND PELVIC ABSCESS ("PELVIC ABCESS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627296) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PATIENT UNDERWENT X-RAY AND DECIDED TO TAKE THE DEVICE OUT. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, DIABETES, HYPERTENSION AND HYPERLIPIDEMIA. CONCOMITANT PRODUCTS INCLUDED ATORVASTATIN, DULAGLUTIDE (TRULICITY), FAMOTIDINE, INSULIN HUMAN;INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN), LOSARTAN AND MELOXICAM. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2017, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), POLYMENORRHOEA ("MORE THAN ONE PERIOD A MONTH"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL DISTENSION ("BLOATING"), UTERINE ENLARGEMENT ("ENLARGED UTERUS"), PAIN ("PAIN"), PELVIC ABSCESS (SERIOUSNESS CRITERION HOSPITALIZATION) AND POST PROCEDURAL INFECTION ("INFECTION POST HYSTERECTOMY"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SUMATRIPTAN (IMITREX), ANTIBIOTICS AND SURGERY (OOPHORECTOMY,SALPINGECTOMY(BILATERAL REMOVAL OF FALLOPIAN TUBES)HYSTERECTOMY (FUL)LYS IS OF ADHESION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, POLYMENORRHOEA, MIGRAINE, DYSPAREUNIA, ABDOMINAL DISTENSION, UTERINE ENLARGEMENT, PAIN, PELVIC ABSCESS AND POST PROCEDURAL INFECTION OUTCOME WAS UNKNOWN AND THE HEADACHE, WEIGHT INCREASED AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, HEADACHE, MIGRAINE, PAIN, PELVIC ABSCESS, PELVIC PAIN, POLYMENORRHOEA, POST PROCEDURAL INFECTION, UTERINE ENLARGEMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE- 2011. DISCREPANCY NOTED AS PER PREVIOUS FOLLOW UP: REMOVAL DATE OF ESSURE: (B)(6) 2018. CURRENT WEIGHT 200 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT AS OF (B)(6) 2019: 270 LBS. COILS VISIBLE: LEFT: 3-5, RIGHT: 3-5. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2008: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-APR-2019: QUALITY SAFETY EVALUATION OF PTC. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN/I WAS HURTING') AND PELVIC ABSCESS ('PELVIC ABCESS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627296) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BROKEN KNEE CAP AND INFECTION. PATIENT UNDERWENT X-RAY AND DECIDED TO TAKE THE DEVICE OUT. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DOXYCYCLINE. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, DIABETES (TYPE - II), HYPERTENSION, HYPERLIPIDEMIA, CONSTIPATION, DIARRHEA, ESOPHAGEAL DISORDER, GASTROESOPHAGEAL REFLUX, HEARTBURN, IRRITABLE BOWEL SYNDROME, OESOPHAGEAL ULCER, ANEMIA, DEPRESSION, BENIGN OVARIAN CYST, FALLOPIAN TUBE ENLARGEMENT, PENICILLIN ALLERGY, PELVIC MASS, PAIN, HEAVY PERIODS, DYSMENORRHEA, DYSPAREUNIA, UTERUS ENLARGED, ADENOMYOSIS AND HYDROSALPINX. CONCOMITANT PRODUCTS INCLUDED ATORVASTATIN, CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), DULAGLUTIDE (TRULICITY), FAMOTIDINE, INSULIN HUMAN;INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN), KETOROLAC TROMETHAMINE (TORADOL), LOSARTAN, MELOXICAM AND OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC ABSCESS (SERIOUSNESS CRITERION HOSPITALIZATION), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), POLYMENORRHOEA ("MORE THAN ONE PERIOD A MONTH"), ABDOMINAL DISTENSION ("BLOATING"), UTERINE ENLARGEMENT ("ENLARGED UTERUS"), PAIN ("PAIN") AND POST PROCEDURAL INFECTION ("INFECTION POST HYSTERECTOMY"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SUMATRIPTAN (IMITREX), ANTIBIOTICS AND SURGERY (OOPHORECTOMY,SALPINGECTOMY(BILATERAL REMOVAL OF FALLOPIAN TUBES)HYSTERECTOMY (FUL)LYS IS OF ADHESION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC ABSCESS, ABDOMINAL PAIN LOWER, POLYMENORRHOEA, MIGRAINE, DYSPAREUNIA, ABDOMINAL DISTENSION, UTERINE ENLARGEMENT, PAIN, POST PROCEDURAL INFECTION AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE HEADACHE, WEIGHT INCREASED AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, PAIN, PELVIC ABSCESS, PELVIC PAIN, POLYMENORRHOEA, POST PROCEDURAL INFECTION, UTERINE ENLARGEMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE- 2011. DISCREPANCY NOTED AS PER PREVIOUS FOLLOW UP: REMOVAL DATE OF ESSURE: (B)(6) 2018. CURRENT WEIGHT 200 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT AS OF (B)(6) 2019: 270 LBS. COILS VISIBLE: LEFT: 3-5, RIGHT: 3-5. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2008: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; CONFIRMING- EVENTS WHICH ARE SAME IN PFS & MR.¿ DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED EVENT "DYSMENORRHEA (CRAMPING)" WAS ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ('PERFORATION: OTHER'), PELVIC PAIN ('PELVIC PAIN/PAIN/I WAS HURTING') AND PELVIC ABSCESS ('PELVIC ABCESS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627296) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "MY UTERUS WAS TILTED, SO IT WAS HARD TO GET THE ESSURE INSIDE.". THE PATIENT'S MEDICAL HISTORY INCLUDED BROKEN KNEE CAP AND INFECTION. PATIENT UNDERWENT X-RAY AND DECIDED TO TAKE THE DEVICE OUT. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DOXYCYCLINE. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, DIABETES (TYPE - II), HYPERTENSION, HYPERLIPIDEMIA, CONSTIPATION, DIARRHEA, ESOPHAGEAL DISORDER, GASTROESOPHAGEAL REFLUX, HEARTBURN, IRRITABLE BOWEL SYNDROME, OESOPHAGEAL ULCER, ANEMIA, DEPRESSION, BENIGN OVARIAN CYST, FALLOPIAN TUBE ENLARGEMENT, PENICILLIN ALLERGY, PELVIC MASS, PAIN, HEAVY PERIODS, DYSMENORRHEA, DYSPAREUNIA, UTERUS ENLARGED, ADENOMYOSIS AND HYDROSALPINX. CONCOMITANT PRODUCTS INCLUDED ATORVASTATIN, CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), DULAGLUTIDE (TRULICITY), FAMOTIDINE, GABAPENTIN SINCE (B)(6) 2019, INSULIN HUMAN;INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN), KETOROLAC TROMETHAMINE (TORADOL), LOSARTAN, MELOXICAM, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), SEMAGLUTIDE SINCE (B)(6) 2019 AND TRIAMCINOLONE (TRIMCORT) SINCE (B)(6) 2019. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2008, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC ABSCESS (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), POLYMENORRHOEA ("MORE THAN ONE PERIOD A MONTH"), ABDOMINAL DISTENSION ("BLOATING"), UTERINE ENLARGEMENT ("ENLARGED UTERUS"), PAIN ("PAIN"), POST PROCEDURAL INFECTION ("INFECTION POST HYSTERECTOMY"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HYPERSENSITIVITY"), SCAR ("I HAD A LOT OF SCARING DUE THE ESSURE."), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEMS") AND VAGINAL INFECTION ("VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SUMATRIPTAN (IMITREX), ANTIBIOTICS AND SURGERY (HYSTERECTOMY (FULL) AND OOPHORECTOMY,SALPINGECTOMY(BILATERAL REMOVAL OF FALLOPIAN TUBES)HYSTERECTOMY (FUL)LYS IS OF ADHESION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PERFORATION, PELVIC ABSCESS, POLYMENORRHOEA, MIGRAINE, ABDOMINAL DISTENSION, UTERINE ENLARGEMENT, POST PROCEDURAL INFECTION, HYPERSENSITIVITY, VAGINAL DISCHARGE, SCAR AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, PAIN, HEADACHE, WEIGHT INCREASED, ABDOMINAL PAIN, DYSMENORRHOEA, VAGINAL HAEMORRHAGE, MENORRHAGIA, BLADDER DISORDER AND VAGINAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PAIN, PELVIC ABSCESS, PELVIC PAIN, PERFORATION, POLYMENORRHOEA, POST PROCEDURAL INFECTION, PSYCHOLOGICAL TRAUMA, SCAR, UTERINE ENLARGEMENT, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE- 2011. DISCREPANCY NOTED AS PER PREVIOUS FOLLOW UP: REMOVAL DATE OF ESSURE: (B)(6) 2018. CURRENT WEIGHT 200 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT AS OF (B)(6) 2019: 270 LBS. COILS VISIBLE: LEFT: 3-5, RIGHT: 3-5. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2008: TOTAL BILATERAL OCCLUSION. TUBES WERE BLOCKED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; CONFIRMING- EVENTS WHICH ARE SAME IN PFS & MR.¿ DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2019: PFS RECEIVED : NEW EVENTS ADDED : "BLADDER/URINARY PROBLEMS: BLADDER PROBLEMS, VAGINAL INFECTION, PSYCH INJURY". OUTCOME OF EVENTS, "DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), BLADDER/URINARY PROBLEMS: BLADDER PROBLEMS, VAGINAL INFECTION, LOWER ABDOMINAL PAIN, PAIN, PELVIC PAIN." WERE CHANGED TO "RECOVERED/RESOLVED". 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN/I WAS HURTING') AND PELVIC ABSCESS ('PELVIC ABCESS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627296) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "MY UTERUS WAS TILTED, SO IT WAS HARD TO GET THE ESSURE INSIDE.". THE PATIENT'S MEDICAL HISTORY INCLUDED BROKEN KNEE CAP AND INFECTION. PATIENT UNDERWENT X-RAY AND DECIDED TO TAKE THE DEVICE OUT. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DOXYCYCLINE. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, DIABETES (TYPE - II), HYPERTENSION, HYPERLIPIDEMIA, CONSTIPATION, DIARRHEA, ESOPHAGEAL DISORDER, GASTROESOPHAGEAL REFLUX, HEARTBURN, IRRITABLE BOWEL SYNDROME, OESOPHAGEAL ULCER, ANEMIA, DEPRESSION, BENIGN OVARIAN CYST, FALLOPIAN TUBE ENLARGEMENT, PENICILLIN ALLERGY, PELVIC MASS, PAIN, HEAVY PERIODS, DYSMENORRHEA, DYSPAREUNIA, UTERUS ENLARGED, ADENOMYOSIS AND HYDROSALPINX. CONCOMITANT PRODUCTS INCLUDED ATORVASTATIN, CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), DULAGLUTIDE (TRULICITY), FAMOTIDINE, GABAPENTIN SINCE (B)(6) 2019, INSULIN HUMAN;INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN), KETOROLAC TROMETHAMINE (TORADOL), LOSARTAN, MELOXICAM, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), SEMAGLUTIDE SINCE (B)(6) 2019 AND TRIAMCINOLONE (TRIMCORT) SINCE (B)(6) 2019. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2008, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC ABSCESS (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), POLYMENORRHOEA ("MORE THAN ONE PERIOD A MONTH"), ABDOMINAL DISTENSION ("BLOATING"), UTERINE ENLARGEMENT ("ENLARGED UTERUS"), PAIN ("PAIN"), POST PROCEDURAL INFECTION ("INFECTION POST HYSTERECTOMY"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HYPERSENSITIVITY") AND SCAR ("I HAD A LOT OF SCARING DUE THE ESSURE."). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SUMATRIPTAN (IMITREX), ANTIBIOTICS AND SURGERY (OOPHORECTOMY,SALPINGECTOMY(BILATERAL REMOVAL OF FALLOPIAN TUBES)HYSTERECTOMY (FUL)LYS IS OF ADHESION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC ABSCESS, ABDOMINAL PAIN LOWER, POLYMENORRHOEA, MIGRAINE, DYSPAREUNIA, ABDOMINAL DISTENSION, UTERINE ENLARGEMENT, PAIN, POST PROCEDURAL INFECTION, DYSMENORRHOEA, HYPERSENSITIVITY, VAGINAL DISCHARGE AND SCAR OUTCOME WAS UNKNOWN AND THE HEADACHE, WEIGHT INCREASED, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PAIN, PELVIC ABSCESS, PELVIC PAIN, POLYMENORRHOEA, POST PROCEDURAL INFECTION, SCAR, UTERINE ENLARGEMENT, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE- 2011. DISCREPANCY NOTED AS PER PREVIOUS FOLLOW UP: REMOVAL DATE OF ESSURE: (B)(6) 2018. CURRENT WEIGHT 200 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT AS OF (B)(6) 2019: 270 LBS. COILS VISIBLE: LEFT: 3-5, RIGHT: 3-5. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2008: TOTAL BILATERAL OCCLUSION. TUBES WERE BLOCKED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; CONFIRMING- EVENTS WHICH ARE SAME IN PFS & MR.¿ DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: NEW PFS AND MR RECEIVED- NEW EVENTS ADDED:ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HYPERSENSITIVITY, VAGINAL DISCHARGE, SCARING, MY UTERUS WAS TILTED, SO IT WAS HARD TO GET THE ESSURE INSIDE WERE ADDED. REPORTER INFORMATION , CONCOMITANT DRUGS WERE ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN/I WAS HURTING") AND PELVIC ABSCESS ("PELVIC ABCESS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627296) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PATIENT UNDERWENT X-RAY AND DECIDED TO TAKE THE DEVICE OUT. CONCURRENT CONDITIONS INCLUDED OBESITY, DIABETES, HYPERTENSION AND HYPERLIPIDEMIA. CONCOMITANT PRODUCTS INCLUDED ATORVASTATIN, DULAGLUTIDE (TRULICITY), FAMOTIDINE, INSULIN HUMAN;INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN), LOSARTAN AND MELOXICAM. ON (B)(6)2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2017, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"). IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), POLYMENORRHOEA ("MORE THAN ONE PERIOD A MONTH"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL DISTENSION ("BLOATING"), UTERINE ENLARGEMENT ("ENLARGED UTERUS"), PAIN ("PAIN"), PELVIC ABSCESS (SERIOUSNESS CRITERION HOSPITALIZATION) AND POST PROCEDURAL INFECTION ("INFECTION POST HYSTERECTOMY"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SUMATRIPTAN (IMITREX), ANTIBIOTICS AND SURGERY (OOPHORECTOMY,SALPINGECTOMY(BILATERAL REMOVAL OF FALLOPIAN TUBES)HYSTERECTOMY (FUL)LYS IS OF ADHESION). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, POLYMENORRHOEA, MIGRAINE, DYSPAREUNIA, ABDOMINAL DISTENSION, UTERINE ENLARGEMENT, PAIN, PELVIC ABSCESS AND POST PROCEDURAL INFECTION OUTCOME WAS UNKNOWN AND THE HEADACHE, WEIGHT INCREASED AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, HEADACHE, MIGRAINE, PAIN, PELVIC ABSCESS, PELVIC PAIN, POLYMENORRHOEA, POST PROCEDURAL INFECTION, UTERINE ENLARGEMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE(B)(6). DISCREPANCY NOTED AS PER PREVIOUS FOLLOW UP: REMOVAL DATE OF ESSURE: (B)(6)2018. CURRENT WEIGHT 200 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT AS OF (B)(6)2019: 270 LBS. COILS VISIBLE: LEFT: 3-5, RIGHT: 3-5. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2008: TOTAL BILATERAL OCCLUSION.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-APR-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. EVENTS ADDED: HEADACHES, WEIGHT GAIN, ABDOMINAL PAIN, PELVIC ABCESS, INFECTION POST HYSTERECTOMY. EVENT OUTCOME WAS UPDATED FOR THE EVENT: ABDOMINAL PAIN, HEADACHES, WEIGHT GAIN. LOT NUMBER WAS ADDED. LAB DATA WAS ADDED. CONCOMITANT AND TREATMENT DRUGS WERE ADDED. CONCOMITANT CONDITIONS WERE ADDED. REPORTER INFORMATION WAS ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INFECTION ("INFECTIONS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), POLYMENORRHOEA ("MORE THAN ONE PERIOD A MONTH"), MIGRAINE ("MIGRAINES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL DISTENSION ("BLOATING"), UTERINE ENLARGEMENT ("ENLARGED UTERUS") AND PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE IMPLANT REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, INFECTION, ABDOMINAL PAIN LOWER, POLYMENORRHOEA, MIGRAINE, DYSPAREUNIA, ABDOMINAL DISTENSION, UTERINE ENLARGEMENT AND PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, DYSPAREUNIA, INFECTION, MIGRAINE, PAIN, PELVIC PAIN, POLYMENORRHOEA AND UTERINE ENLARGEMENT TO BE RELATED TO ESSURE. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272385 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 627296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O| R | ATORVASTATIN| ATORVASTATIN| ATORVASTATIN| ATORVASTATIN| ATORVASTATIN| FAMOTIDINE| FAMOTIDINE| FAMOTIDINE| FAMOTIDINE| FAMOTIDINE| GABAPENTIN| GABAPENTIN| LOSARTAN| LOSARTAN| LOSARTAN| LOSARTAN| LOSARTAN| MELOXICAM| MELOXICAM| MELOXICAM| MELOXICAM| MELOXICAM| NOVOLIN| NOVOLIN| NOVOLIN| NOVOLIN| NOVOLIN| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| SEMAGLUTIDE| SEMAGLUTIDE| TORADOL| TORADOL| TORADOL| TRIMCORT [TRIAMCINOLONE]| TRIMCORT [TRIAMCINOLONE]| TRULICITY| TRULICITY| TRULICITY| TRULICITY| TRULICITY| TYLENOL WITH CODEINE NO.3| TYLENOL WITH CODEINE NO.3| TYLENOL WITH CODEINE NO.3 |