ESSURE
Report
- Report Number
- 2951250-2019-10258
- Event Type
- Injury
- Date Received
- October 14, 2019
- Date of Event
- January 1, 2012
- Report Date
- February 18, 2020
- 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION OF LEFT FALLOPIAN TUBE/MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE WAS MALPOSITIONED/ MIGRATION OF LEFT ESSURE/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)'), DEVICE BREAKAGE ('DEVICE BREAKAGE'), SALPINGITIS ('CHRONIC SALPINGITIS') AND OOPHORITIS ('OOPHORITIS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "COMPLICATIONS AT TIME OF ESSURE REMOVAL PROCEDURE: THE LEFT COIL WAS HARD TO REMOVE". THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II AND URINARY TRACT INFECTION. CONCURRENT CONDITIONS INCLUDED GASTRIC BYPASS, MULTIPLE SCLEROSIS, HYDROSALPINX AND CERVIX NEOPLASM. CONCOMITANT PRODUCTS INCLUDED BULK-FORMING LAXATIVES FOR CONSTIPATION AS WELL AS LEVONORGESTREL (MIRENA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MOOD ALTERED ("HORMONAL CHANGES DESCRIBE: MOODY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/ PSYCH INJURY"), TOOTH DISORDER ("DENTAL PROBLEMS") AND DYSGEUSIA ("METALLIC TASTE IN MOUTH"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: DRY SKIN RASHES") AND MIGRAINE ("MIGRAINES / HEADACHES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION"). IN (B)(6) 2014, THE PATIENT EXPERIENCED CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION"). IN (B)(6) 2017, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OOPHORITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("MENSTRUAL PAIN"), ADNEXA UTERI CYST ("COMPLICATIONS AT TIME OF ESSURE REMOVAL PROCEDURE: PARATUBAL CYSTS ON BOTH FALLOPIAN TUBES") AND PELVIC PAIN ("PELVIC PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, SALPINGITIS, OOPHORITIS, MOOD ALTERED, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY, URINARY TRACT DISORDER, MIGRAINE, TOOTH DISORDER, WEIGHT INCREASED, DYSGEUSIA, DYSMENORRHOEA, ADNEXA UTERI CYST AND PELVIC PAIN OUTCOME WAS UNKNOWN, THE RASH, BLADDER DISORDER, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL DISCHARGE AND VISION BLURRED HAD RESOLVED AND THE CONSTIPATION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI CYST, ANXIETY, BLADDER DISORDER, CONSTIPATION, DEVICE BREAKAGE, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, MIGRAINE, MOOD ALTERED, OOPHORITIS, PELVIC PAIN, RASH, SALPINGITIS, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE RIGHT TUBE HAS 6 TRAILING COILS, THE LEFT TUBE HAS 3 TRAILING COILS. (B)(6) 2012, (B)(6) 2018-UNILATERAL SALPINGECTOMY, BILATERAL SALPINGECTOMY( AS PER PFS) (B)(6) 2018-BILATERAL SALPINGECTOMY CURRENT WEIGHT 212LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED)/ PERFORATION OF LEFT FALLOPIAN TUBE. ULTRASOUND SCAN - ON (B)(6) 2012: IUD WITHIN THE UTERINE CAVITY. RIGHT ESSURE COIL IN THE PROPER POSITION, LEFT ESSURE COIL LIKELY WITHIN THE LEFT FALLOPIAN TUBE WITH POSSIBLE PERFORATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-OCT-2019: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 FALLOPIAN TUBE PERFORATION ('PERFORATION OF LEFT FALLOPIAN TUBE/MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE WAS MALPOSITIONED/ MIGRATION OF LEFT ESSURE/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S) /MIGRATION OF ESSURE DEVICE: LEFT ESSURE WAS PARTIALLY TANGLED'), DEVICE BREAKAGE ('DEVICE BREAKAGE') AND SALPINGITIS ('CHRONIC SALPINGITIS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "LEFT ESSURE WAS PARTIALLY TANGLED WITH MIRENA IN UTERUS" AND DEVICE DIFFICULT TO USE "COMPLICATIONS AT TIME OF ESSURE REMOVAL PROCEDURE: THE LEFT COIL WAS HARD TO REMOVE". THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II AND URINARY TRACT INFECTION. CONCURRENT CONDITIONS INCLUDED GASTRIC BYPASS, MULTIPLE SCLEROSIS, HYDROSALPINX AND CERVIX NEOPLASM. CONCOMITANT PRODUCTS INCLUDED BULK-FORMING LAXATIVES FOR CONSTIPATION AS WELL AS LEVONORGESTREL (MIRENA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MOOD ALTERED ("HORMONAL CHANGES DESCRIBE: MOODY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/ PSYCH INJURY"), TOOTH DISORDER ("DENTAL PROBLEMS") AND DYSGEUSIA ("METALLIC TASTE IN MOUTH"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: DRY SKIN RASHES") AND MIGRAINE ("MIGRAINES / HEADACHES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION"). IN (B)(6) 2014, THE PATIENT EXPERIENCED CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION"). IN (B)(6) 2017, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OOPHORITIS ("OOPHORITIS"), DYSMENORRHOEA ("MENSTRUAL PAIN"), ADNEXA UTERI CYST ("COMPLICATIONS AT TIME OF ESSURE REMOVAL PROCEDURE: PARATUBAL CYSTS ON BOTH FALLOPIAN TUBES") AND PELVIC PAIN ("PELVIC PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, SALPINGITIS, OOPHORITIS, MOOD ALTERED, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY, URINARY TRACT DISORDER, MIGRAINE, TOOTH DISORDER, WEIGHT INCREASED, DYSGEUSIA, DYSMENORRHOEA, ADNEXA UTERI CYST AND PELVIC PAIN OUTCOME WAS UNKNOWN, THE RASH, BLADDER DISORDER, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL DISCHARGE AND VISION BLURRED HAD RESOLVED AND THE CONSTIPATION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI CYST, ANXIETY, BLADDER DISORDER, CONSTIPATION, DEVICE BREAKAGE, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, MIGRAINE, MOOD ALTERED, OOPHORITIS, PELVIC PAIN, RASH, SALPINGITIS, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE RIGHT TUBE HAS 6 TRAILING COILS, THE LEFT TUBE HAS 3 TRAILING COILS. (B)(6) 2012, (B)(6) 2018-UNILATERAL SALPINGECTOMY, BILATERAL SALPINGECTOMY( AS PER PFS) (B)(6) 2018-BILATERAL SALPINGECTOMY CURRENT WEIGHT 212LBS. RECEIVED TREATMENT FOR DEVICE PHYSICAL PROPERTY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED)/ PERFORATION OF LEFT FALLOPIAN TUBE. ULTRASOUND SCAN - ON (B)(6) 2012: IUD WITHIN THE UTERINE CAVITY. RIGHT ESSURE COIL IN THE PROPER POSITION, LEFT ESSURE COIL LIKELY WITHIN THE LEFT FALLOPIAN TUBE WITH POSSIBLE PERFORATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-FEB-2020: PFS: NEW EVENT: DEVICE PHYSICAL PROPERTIES ISSUE WAS ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION OF LEFT FALLOPIAN TUBE/MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE WAS MALPOSITIONED/ MIGRATION OF LEFT ESSURE/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)'), DEVICE BREAKAGE ('DEVICE BREAKAGE'), SALPINGITIS ('CHRONIC SALPINGITIS') AND OOPHORITIS ('OOPHORITIS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "COMPLICATIONS AT TIME OF ESSURE REMOVAL PROCEDURE: THE LEFT COIL WAS HARD TO REMOVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND URINARY TRACT INFECTION. CONCURRENT CONDITIONS INCLUDED GASTRIC BYPASS, MULTIPLE SCLEROSIS, HYDROSALPINX AND CERVIX NEOPLASM. CONCOMITANT PRODUCTS INCLUDED BULK-FORMING LAXATIVES FOR CONSTIPATION AS WELL AS LEVONORGESTREL (MIRENA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MOOD ALTERED ("HORMONAL CHANGES DESCRIBE: MOODY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/ PSYCH INJURY"), TOOTH DISORDER ("DENTAL PROBLEMS") AND DYSGEUSIA ("METALLIC TASTE IN MOUTH"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: DRY SKIN RASHES") AND MIGRAINE ("MIGRAINES/HEADACHES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION"). IN (B)(6) 2014, THE PATIENT EXPERIENCED CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION"). IN (B)(6) 2017, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OOPHORITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("MENSTRUAL PAIN"), ADNEXA UTERI CYST ("COMPLICATIONS AT TIME OF ESSURE REMOVAL PROCEDURE: PARATUBAL CYSTS ON BOTH FALLOPIAN TUBES") AND PELVIC PAIN ("PELVIC PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, SALPINGITIS, OOPHORITIS, MOOD ALTERED, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY, URINARY TRACT DISORDER, MIGRAINE, TOOTH DISORDER, WEIGHT INCREASED, DYSGEUSIA, DYSMENORRHOEA, ADNEXA UTERI CYST AND PELVIC PAIN OUTCOME WAS UNKNOWN, THE RASH, BLADDER DISORDER, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL DISCHARGE AND VISION BLURRED HAD RESOLVED AND THE CONSTIPATION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI CYST, ANXIETY, BLADDER DISORDER, CONSTIPATION, DEVICE BREAKAGE, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, MIGRAINE, MOOD ALTERED, OOPHORITIS, PELVIC PAIN, RASH, SALPINGITIS, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE RIGHT TUBE HAS 6 TRAILING COILS, THE LEFT TUBE HAS 3 TRAILING COILS. (B)(6) 2012, (B)(6) 2018-UNILATERAL SALPINGECTOMY, BILATERAL SALPINGECTOMY(AS PER PFS) (B)(6) 2018-BILATERAL SALPINGECTOMY CURRENT WEIGHT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2012: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED)/PERFORATION OF LEFT FALLOPIAN TUBE. ULTRASOUND SCAN ON (B)(6) 2012: IUD WITHIN THE UTERINE CAVITY. RIGHT ESSURE COIL IN THE PROPER POSITION, LEFT ESSURE COIL LIKELY WITHIN THE LEFT FALLOPIAN TUBE WITH POSSIBLE PERFORATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PLAINTIFF FACT SHEET AND MEDICAL RECORDS WERE RECEIVED. EVENT INJURY WAS UPDATED TO EVENTS: PERFORATION OF LEFT FALLOPIAN TUBE/MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT ESSURE WAS MALPOSITIONED/MIGRATION OF LEFT ESSURE/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S), DEVICE BREAKAGE, HORMONAL CHANGES DESCRIBE: MOODY, ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/ PSYCH INJURY, RASHES OR SKIN CONDITIONS TYPE: DRY SKIN RASHES, BLADDER PROBLEMS, URINARY PROBLEMS, MIGRAINES/HEADACHES, DENTAL PROBLEMS, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), ABDOMINAL PAIN, VAGINAL DISCHARGE, VISION/EYE PROBLEMS TYPE: BLURRY VISION, WEIGHT GAIN, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION, METALLIC TASTE IN MOUTH, MENSTRUAL PAIN, COMPLICATIONS AT TIME OF ESSURE REMOVAL PROCEDURE: THE LEFT COIL WAS HARD TO REMOVE, COMPLICATIONS AT TIME OF ESSURE REMOVAL PROCEDURE: PARATUBAL CYSTS ON BOTH FALLOPIAN TUBES AND PELVIC PAIN. EVENTS PER MR: CHRONIC SALPINGITIS AND OOPHORITIS. LOT NUMBER, MEDICAL HISTORY AND CONCURRENT CONDITION WERE ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 978066 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863581 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R | BULK-FORMING LAXATIVES| BULK-FORMING LAXATIVES| BULK-FORMING LAXATIVES| MIRENA| MIRENA| MIRENA |