ESSURE
Report
- Report Number
- 2951250-2020-12905
- Event Type
- Malfunction
- Date Received
- August 7, 2020
- Report Date
- February 23, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('ESSURE DISLOCATED (NEAR TO PERFURATE HER INTERNAL ORGANS)') AND DEVICE BREAKAGE ('ESSURE FRAGMENTATION') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 AND GRAVIDA II. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SLIGHT LOWER ABDOMINAL PAIN"). IN 2017, THE PATIENT EXPERIENCED HEADACHE ("CEPHALEA"), NAUSEA ("NAUSEA"), MENORRHAGIA ("MENSTRUAL FLOW INCREASED WITH CLOTS"), BACK PAIN ("LUMBAR PAIN"), DYSMENORRHOEA ("PAIN DURING MENSES"), VAGINAL DISCHARGE ("INCREASE OF VAGINAL SECRETION"), ANXIETY ("ANXIETY") AND MOOD ALTERED ("MOOD CHANGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH ANALGESICS AND ANTIINFLAMMATORY AGENTS. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, HEADACHE, NAUSEA, MENORRHAGIA, BACK PAIN, DYSMENORRHOEA, VAGINAL DISCHARGE, ANXIETY AND MOOD ALTERED HAD NOT RESOLVED AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, HEADACHE, MENORRHAGIA, MOOD ALTERED, NAUSEA AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): X-RAY - ON AN UNKNOWN DATE: ESSURE DISLOCATED, IN EMINENCE OF TO PERFORATE THE INTERNAL ORGANS. ESSURE FRAGMENTED IN SEVERAL PARTS.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-AUG-2020: QUALITY-SAFETY EVALUATION OF PTC 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 DEVICE DISLOCATION ('ESSURE DISLOCATED (NEAR TO PERFURATE HER INTERNAL ORGANS)'), DEVICE BREAKAGE ('ESSURE FRAGMENTATION') AND UTERINE PERFORATION ('SENSATION OF PERFORATION IN THE UTERUS ') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 AND GRAVIDA II. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SLIGHT LOWER ABDOMINAL PAIN / HEAVY ABDOMINAL COLIC / SEVERE CRAMPS IN LOWER ABDOMEN, LIKE TWINGES / SEVERE CRAMPS"). IN 2017, THE PATIENT EXPERIENCED HEADACHE ("CEPHALEA / SEVERE HEADACHE"), NAUSEA ("NAUSEA"), MENORRHAGIA ("MENSTRUAL FLOW INCREASED WITH CLOTS"), BACK PAIN ("LUMBAR PAIN"), DYSMENORRHOEA ("PAIN DURING MENSES"), VAGINAL DISCHARGE ABNORMALITY ("INCREASE OF VAGINAL SECRETION"), ANXIETY DISORDER ("ANXIETY DISTURBANCE"), MOOD ALTERED ("MOOD CHANGE"), POLYMENORRHAGIA ("CONSIDERABLE INCREASE IN HER MENSTRUAL FLOW / MENSTRUATION LASTING 15 DAYS WITH SOME CLOTS/ INCREASE IN MENSTRUAL FREQUENCY") AND DYSPAREUNIA ("PAIN DURING AND AFTER SEXUAL INTERCOURSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("DISTENSION"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), PELVIC PAIN ("PELVIC PAIN"), OFFENSIVE VAGINAL DISCHARGE ("ODOR FROM VAGINAL DISCHARGE / INCREASED OF VAGINAL DISCHARGE"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), ARTHRALGIA ("JOINT PAIN"), COITAL BLEEDING ("BLEEDING DURING AND AFTER SEXUAL INTERCOURSE"), INTRA-ABDOMINAL FLUID COLLECTION ("FLUID IN THE ABDOMEN"), BREAST PAIN ("MASTALGIA"), OEDEMA ("OEDEMA"), PAIN IN EXTREMITY ("LEG PAIN"), PERIPHERAL SWELLING ("SWELLING IN HER LEGS"), TREMOR ("TREMORS"), PARAESTHESIA ("TINGLING"), LOSS OF LIBIDO ("LACK OF LIBIDO"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), PAIN ("GENERALIZED PAIN"), NERVOUSNESS ("NERVOUSNESS") AND STRESS ("STRESS"). THE PATIENT WAS TREATED WITH ANALGESICS AND ANTIINFLAMMATORY AGENTS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, HEADACHE, NAUSEA, MENORRHAGIA, BACK PAIN, DYSMENORRHOEA, VAGINAL DISCHARGE ABNORMALITY, ANXIETY DISORDER AND MOOD ALTERED HAD NOT RESOLVED, THE UTERINE PERFORATION, ABDOMINAL DISTENSION, POLYMENORRHAGIA, DYSPAREUNIA, UTERINE INFLAMMATION, PELVIC PAIN, OFFENSIVE VAGINAL DISCHARGE, ADENOMYOSIS, ARTHRALGIA, COITAL BLEEDING, INTRA-ABDOMINAL FLUID COLLECTION, BREAST PAIN, OEDEMA, PAIN IN EXTREMITY, PERIPHERAL SWELLING, TREMOR, PARAESTHESIA, LOSS OF LIBIDO, FATIGUE, ALOPECIA, PAIN, NERVOUSNESS AND STRESS OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MENORRHAGIA, MOOD ALTERED, NAUSEA, NERVOUSNESS, OEDEMA, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, POLYMENORRHAGIA, STRESS, TREMOR, UTERINE INFLAMMATION, UTERINE PERFORATION, VAGINAL DISCHARGE ABNORMALITY AND OFFENSIVE VAGINAL DISCHARGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): X-RAY - ON AN UNKNOWN DATE: ESSURE DISLOCATED, IN EMINENCE OF TO PERFORATE THE INTERNAL ORGANS. ESSURE FRAGMENTED IN SEVERAL PARTS.; ON (B)(6) 2019: ESSURE ON LEFT AND RIGHT PELVIS. LOT NUMBER: 882183. MANUFACTURING DATE: 2011/07. EXPIRATION DATE: 2014/07. 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 22-FEB-2021: QUALITY-SAFETY EVALUATION OF PTC. 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 DEVICE DISLOCATION ('ESSURE DISLOCATED (NEAR TO PERFURATE HER INTERNAL ORGANS)'), DEVICE BREAKAGE ('ESSURE FRAGMENTATION') AND UTERINE PERFORATION ('SENSATION OF PERFORATION IN THE UTERUS ') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 AND GRAVIDA II. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SLIGHT LOWER ABDOMINAL PAIN / HEAVY ABDOMINAL COLIC / SEVERE CRAMPS IN LOWER ABDOMEN, LIKE TWINGES / SEVERE CRAMPS"). IN 2017, THE PATIENT EXPERIENCED HEADACHE ("CEPHALEA / SEVERE HEADACHE"), NAUSEA ("NAUSEA"), BLEEDING MENSTRUAL HEAVY ("MENSTRUAL FLOW INCREASED WITH CLOTS"), BACK PAIN ("LUMBAR PAIN"), DYSMENORRHOEA ("PAIN DURING MENSES"), VAGINAL DISCHARGE ABNORMALITY ("INCREASE OF VAGINAL SECRETION"), ANXIETY DISORDER ("ANXIETY DISTURBANCE"), MOOD ALTERED ("MOOD CHANGE"), MENORRHAGIA ("CONSIDERABLE INCREASE IN HER MENSTRUAL FLOW / MENSTRUATION LASTING 15 DAYS WITH SOME CLOTS/ INCREASE IN MENSTRUAL FREQUENCY") AND DYSPAREUNIA ("PAIN DURING AND AFTER SEXUAL INTERCOURSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("DISTENSION"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), PELVIC PAIN ("PELVIC PAIN"), OFFENSIVE VAGINAL DISCHARGE ("ODOR FROM VAGINAL DISCHARGE / INCREASED OF VAGINAL DISCHARGE"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), ARTHRALGIA ("JOINT PAIN"), COITAL BLEEDING ("BLEEDING DURING AND AFTER SEXUAL INTERCOURSE"), INTRA-ABDOMINAL FLUID COLLECTION ("FLUID IN THE ABDOMEN"), BREAST PAIN ("MASTALGIA"), OEDEMA ("OEDEMA"), PAIN IN EXTREMITY ("LEG PAIN"), PERIPHERAL SWELLING ("SWELLING IN HER LEGS"), TREMOR ("TREMORS"), PARAESTHESIA ("TINGLING"), LOSS OF LIBIDO ("LACK OF LIBIDO"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), PAIN ("GENERALIZED PAIN"), NERVOUSNESS ("NERVOUSNESS") AND STRESS ("STRESS"). THE PATIENT WAS TREATED WITH ANALGESICS AND ANTIINFLAMMATORY AGENTS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, HEADACHE, NAUSEA, BLEEDING MENSTRUAL HEAVY, BACK PAIN, DYSMENORRHOEA, VAGINAL DISCHARGE ABNORMALITY, ANXIETY DISORDER AND MOOD ALTERED HAD NOT RESOLVED, THE UTERINE PERFORATION, ABDOMINAL DISTENSION, MENORRHAGIA, DYSPAREUNIA, UTERINE INFLAMMATION, PELVIC PAIN, OFFENSIVE VAGINAL DISCHARGE, ADENOMYOSIS, ARTHRALGIA, COITAL BLEEDING, INTRA-ABDOMINAL FLUID COLLECTION, BREAST PAIN, OEDEMA, PAIN IN EXTREMITY, PERIPHERAL SWELLING, TREMOR, PARAESTHESIA, LOSS OF LIBIDO, FATIGUE, ALOPECIA, PAIN, NERVOUSNESS AND STRESS OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BLEEDING MENSTRUAL HEAVY, BREAST PAIN, COITAL BLEEDING, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MOOD ALTERED, NAUSEA, NERVOUSNESS, OEDEMA, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, STRESS, TREMOR, UTERINE INFLAMMATION, UTERINE PERFORATION, VAGINAL DISCHARGE ABNORMALITY, MENORRHAGIA AND OFFENSIVE VAGINAL DISCHARGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): X-RAY - ON AN UNKNOWN DATE: ESSURE DISLOCATED, IN EMINENCE OF TO PERFORATE THE INTERNAL ORGANS. ESSURE FRAGMENTED IN SEVERAL PARTS.; ON 10-SEP-2019: ESSURE ON LEFT AND RIGHT PELVIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: LAB DATA; NEW EVENTS WERE ADDED: SENSATION OF PERFORATION IN THE UTERUS / TWINGES, DISTENSION, CONSIDERABLE INCREASE IN HER MENSTRUAL FLOW / MENSTRUATION LASTING 15 DAYS WITH SOME CLOTS/ INCREASE IN MENSTRUAL FREQUENCY, PAIN DURING AND AFTER SEXUAL INTERCOURSE, PELVIC PAIN, UTERINE INFLAMMATION, ODOR FROM VAGINAL DISCHARGE / INCREASED OF VAGINAL DISCHARGE, SUSPICION OF ADENOMYOSIS, BLEEDING DURING AND AFTER SEXUAL INTERCOURSE, JOINT PAIN, FLUID IN THE ABDOMEN, MASTALGIA, LEG PAIN, SWELLING IN HER LEGS, TINGLING, TREMORS, FATIGUE, LACK OF LIBIDO, HAIR LOSS, GENERALIZED PAIN, NERVOUSNESS, STRESS ON 8-FEB-2021: NO NEW INFORMATION. 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 DEVICE DISLOCATION ('ESSURE DISLOCATED (NEAR TO PERFURATE HER INTERNAL ORGANS)') AND DEVICE BREAKAGE ('ESSURE FRAGMENTATION') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SLIGHT LOWER ABDOMINAL PAIN"). IN 2017, THE PATIENT EXPERIENCED HEADACHE ("CEPHALEA"), NAUSEA ("NAUSEA"), MENORRHAGIA ("MENSTRUAL FLOW INCREASED WITH CLOTS"), BACK PAIN ("LUMBAR PAIN"), DYSMENORRHOEA ("PAIN DURING MENSES"), VAGINAL DISCHARGE ("INCREASE OF VAGINAL SECRETION"), ANXIETY ("ANXIETY") AND MOOD ALTERED ("MOOD CHANGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH ANALGESICS AND ANTIINFLAMMATORY AGENTS. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, HEADACHE, NAUSEA, MENORRHAGIA, BACK PAIN, DYSMENORRHOEA, VAGINAL DISCHARGE, ANXIETY AND MOOD ALTERED HAD NOT RESOLVED AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, HEADACHE, MENORRHAGIA, MOOD ALTERED, NAUSEA AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): X-RAY - ON AN UNKNOWN DATE: ESSURE DISLOCATED, IN EMINENCE OF TO PERFORATE THE INTERNAL ORGANS. ESSURE FRAGMENTED IN SEVERAL PARTS. 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 |
|---|---|---|---|---|---|---|---|
| 843895 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882183 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other |