ESSURE
Report
- Report Number
- 2951250-2019-04525
- Event Type
- Injury
- Date Received
- August 7, 2019
- Date of Event
- August 13, 2018
- Report Date
- October 23, 2019
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MOVED OUT OF THE TUBE'), FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S))') AND UTERINE PERFORATION ('PERFORATION (UTERUS)') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GERD, NERVOUS SYSTEM DISORDER AND VITAMIN D DEFICIENCY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CONDOM, COPPER AND MIRENA. CONCURRENT CONDITIONS INCLUDED CONSTIPATION, DYSPHASIA, FLANK PAIN, EYE PAIN, FIBROMYALGIA, PAIN IN ELBOW, MUSCLE STRAIN, ADENOMYOSIS AND DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA) SINCE (B)(6) 2014, CORTISONE, DEXAMETHASONE, DEXAMETHASONE, FEXOFENADINE, FLUTICASONE, HYDROCORTISONE, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), METHYLPREDNISOLONE, PREDNISOLONE AND PREDNISONE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING") AND FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED BOWEL MOVEMENT IRREGULARITY ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: IRREGULAR BOWEL MOVEMENT"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PRURITUS ("RASHES OR SKIN CONDITIONS TYPE: ITCHY SKIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA"), ANXIETY ("ANXIETY") AND RASH ("RASHES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, MOOD SWINGS, DEPRESSION, ANXIETY, PRURITUS, URINARY TRACT DISORDER, PELVIC PAIN, BOWEL MOVEMENT IRREGULARITY AND FATIGUE OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, BLADDER DISORDER, DYSPAREUNIA, VAGINAL DISCHARGE, ALOPECIA AND RASH HAD RESOLVED AND THE MENORRHAGIA WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, BLADDER DISORDER, BOWEL MOVEMENT IRREGULARITY, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PRURITUS, RASH, URINARY TRACT DISORDER, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE MICROINSERTS WERE PLACED INTO EACH TUBAL OSTIA WITHOUT DIFFICULT. 1 COIL WAS VISIBLE ON THE LEFT OSTIA, 3 COILS WERE COILS WERE VISIBLE IN THE RIGHT OSTIA AFTER THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULT: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-AUG-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. AND NON-DRUG TREATMENT RECEIVED (SURGERY) AND NON-DRUG TREATMENT NOTES (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) ADDED FOR INCIDENT EVENTS. 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 DEVICE BREAKAGE ('DEVICE BREAKAGE'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MOVED OUT OF THE TUBE'), FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S))') AND UTERINE PERFORATION ('PERFORATION (UTERUS)/ DEVICE EXPULSION') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GERD, NERVOUS SYSTEM DISORDER AND VITAMIN D DEFICIENCY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CONDOM, COPPER AND MIRENA. CONCURRENT CONDITIONS INCLUDED CONSTIPATION, DYSPHASIA, FLANK PAIN, EYE PAIN, FIBROMYALGIA, PAIN IN ELBOW, MUSCLE STRAIN, ADENOMYOSIS AND DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA) SINCE (B)(6) 2014, CORTISONE, DEXAMETHASONE, DEXAMETHASONE, FEXOFENADINE, FLUTICASONE, HYDROCORTISONE, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), METHYLPREDNISOLONE, PREDNISOLONE AND PREDNISONE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING") AND FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED BOWEL MOVEMENT IRREGULARITY ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: IRREGULAR BOWEL MOVEMENT"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PRURITUS ("RASHES OR SKIN CONDITIONS TYPE: ITCHY SKIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA"), ANXIETY ("ANXIETY"), RASH ("RASHES") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, MOOD SWINGS, DEPRESSION, ANXIETY, PRURITUS, URINARY TRACT DISORDER, PELVIC PAIN, BOWEL MOVEMENT IRREGULARITY, FATIGUE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, BLADDER DISORDER, DYSPAREUNIA, VAGINAL DISCHARGE, ALOPECIA AND RASH HAD RESOLVED AND THE MENORRHAGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BLADDER DISORDER, BOWEL MOVEMENT IRREGULARITY, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PRURITUS, RASH, URINARY TRACT DISORDER, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE MICROINSERTS WERE PLACED INTO EACH TUBAL OSTIA WITHOUT DIFFICULT. 1 COIL WAS VISIBLE ON THE LEFT OSTIA, 3 COILS WERE COILS WERE VISIBLE IN THE RIGHT OSTIA AFTER THE PROCEDURE. SHE HAD RECEIVED TREATMENT FOR PAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULT: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-SEP-2019: PFS RECEIVED: EVENT WAS ADDED- DEVICE BREAKAGE AND ABDOMINAL PAIN. EVENT WAS CLUBBED- PERFORATION (UTERUS)/ DEVICE EXPULSION. INCIDENT WE RECEIVED A LOT NUMBER. 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 DEVICE BREAKAGE ('DEVICE BREAKAGE'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MOVED OUT OF THE TUBE'), FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S))') AND UTERINE PERFORATION ('PERFORATION (UTERUS)/ DEVICE EXPULSION') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GERD, NERVOUS SYSTEM DISORDER AND VITAMIN D DEFICIENCY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CONDOM, COPPER AND MIRENA. CONCURRENT CONDITIONS INCLUDED CONSTIPATION, DYSPHASIA, FLANK PAIN, EYE PAIN, FIBROMYALGIA, PAIN IN ELBOW, MUSCLE STRAIN, ADENOMYOSIS AND DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA) SINCE (B)(6) 2014, CORTISONE, DEXAMETHASONE, DEXAMETHASONE, FEXOFENADINE, FLUTICASONE, HYDROCORTISONE, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), METHYLPREDNISOLONE, PREDNISOLONE AND PREDNISONE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING") AND FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED BOWEL MOVEMENT IRREGULARITY ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: IRREGULAR BOWEL MOVEMENT"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PRURITUS ("RASHES OR SKIN CONDITIONS TYPE: ITCHY SKIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENORRHAGIA"), ANXIETY ("ANXIETY"), RASH ("RASHES") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, MOOD SWINGS, DEPRESSION, ANXIETY, PRURITUS, URINARY TRACT DISORDER, PELVIC PAIN, BOWEL MOVEMENT IRREGULARITY, FATIGUE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, BLADDER DISORDER, DYSPAREUNIA, VAGINAL DISCHARGE, ALOPECIA AND RASH HAD RESOLVED AND THE MENORRHAGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BLADDER DISORDER, BOWEL MOVEMENT IRREGULARITY, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PRURITUS, RASH, URINARY TRACT DISORDER, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE MICROINSERTS WERE PLACED INTO EACH TUBAL OSTIA WITHOUT DIFFICULT. 1 COIL WAS VISIBLE ON THE LEFT OSTIA, 3 COILS WERE COILS WERE VISIBLE IN THE RIGHT OSTIA AFTER THE PROCEDURE. SHE HAD RECEIVED TREATMENT FOR PAIN DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULT: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 882183 MANUFACTURING DATE: 2011/07 EXPIRATION DATE: 2014/07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY-SAFETY EVALUATION OF 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 DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MOVED OUT OF THE TUBE'), FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S))') AND UTERINE PERFORATION ('PERFORATION (UTERUS)') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GERD, NERVOUS SYSTEM DISORDER AND VITAMIN D DEFICIENCY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CONDOM, COPPER AND MIRENA. CONCURRENT CONDITIONS INCLUDED CONSTIPATION, DYSPHASIA, FLANK PAIN, EYE PAIN, FIBROMYALGIA, PAIN IN ELBOW, MUSCLE STRAIN, ADENOMYOSIS AND DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA) SINCE JUNE 2014, CORTISONE, DEXAMETHASONE, DEXAMETHASONE, FEXOFENADINE, FLUTICASONE, HYDROCORTISONE, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), METHYLPREDNISOLONE, PREDNISOLONE AND PREDNISONE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING") AND FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED BOWEL MOVEMENT IRREGULARITY ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: IRREGULAR BOWEL MOVEMENT"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PRURITUS ("RASHES OR SKIN CONDITIONS TYPE: ITCHY SKIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA"), ANXIETY ("ANXIETY") AND RASH ("RASHES"). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, MOOD SWINGS, DEPRESSION, ANXIETY, PRURITUS, URINARY TRACT DISORDER, PELVIC PAIN, BOWEL MOVEMENT IRREGULARITY AND FATIGUE OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, BLADDER DISORDER, DYSPAREUNIA, VAGINAL DISCHARGE, ALOPECIA AND RASH HAD RESOLVED AND THE MENORRHAGIA WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, BLADDER DISORDER, BOWEL MOVEMENT IRREGULARITY, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PRURITUS, RASH, URINARY TRACT DISORDER, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE MICROINSERTS WERE PLACED INTO EACH TUBAL OSTIA WITHOUT DIFFICULT. 1 COIL WAS VISIBLE ON THE LEFT OSTIA, 3 COILS WERE COILS WERE VISIBLE IN THE RIGHT OSTIA AFTER THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2013: RESULT: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-JUL-2019: PFS RECEIVED. LOT NUMBER AND LAB DATA ADDED. CONCOMITANT MEDICATION AND CONDITION ADDED. EVENTS : MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MOVED OUT OF THE TUBE, PERFORATION (FALLOPIAN TUBE(S)), PERFORATION (UTERUS), HORMONAL CHANGES DESCRIBE: MOOD SWING, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, ANXIETY, RASHES OR SKIN CONDITIONS TYPE: ITCHY SKIN, BLADDER OR URINARY PROBLEMS OR CHANGES, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, VAGINAL DISCHARGE, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: IRREGULAR BOWEL MOVEMENT, HAIR LOSS, FATIGUE, RASHES 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666128 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882183 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R | CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CORTISONE| CORTISONE| CORTISONE| CORTISONE| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEXAMETHASONE| DEXAMETHASONE| DEXAMETHASONE| DEXAMETHASONE| DEXAMETHASONE| DEXAMETHASONE| DEXAMETHASONE| DEXAMETHASONE| FEXOFENADINE| FEXOFENADINE| FEXOFENADINE| FEXOFENADINE| FLUTICASONE| FLUTICASONE| FLUTICASONE| FLUTICASONE| HYDROCORTISONE| HYDROCORTISONE| HYDROCORTISONE| HYDROCORTISONE| METHYLPREDNISOLONE| METHYLPREDNISOLONE| METHYLPREDNISOLONE| METHYLPREDNISOLONE| PREDNISOLONE| PREDNISOLONE| PREDNISOLONE| PREDNISOLONE| PREDNISONE| PREDNISONE| PREDNISONE| PREDNISONE |