ESSURE
Report
- Report Number
- 2951250-2019-01176
- Event Type
- Injury
- Date Received
- March 20, 2019
- Date of Event
- April 1, 2015
- Report Date
- March 8, 2022
- 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
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('THE PORTION OF THE ESSURE WAS LEFT IN THE RIGHT FALLOPIAN TUBE'), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY/ ECTOPIC PREGNANCY'), UTERINE PERFORATION ('UTERINE PERFORATION'), HAEMORRHAGE IN PREGNANCY ('EARLY PREGNANCY BLEEDING'), DEVICE DISLOCATION ('ESSURE DEVICE WAS NOTED TO BE ADHERE TO THE LEFT ABDOMINAL WALL/ESSURE WAS NOT IN PLACE IN THE LEFT FALLOPIAN TUBE'), CUSHING'S SYNDROME ('HORMONAL CHANGES DESCRIBE: CUSHION SYNDROME'), ABORTION THREATENED ('THREATENED ABORTION') AND GENITAL HAEMORRHAGE ('HEAVY ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED RENAL SURGERY. ESSURE CONFIRMATION TEST WAS DONE:- ONE TUBE OCCLUDED BUT UNSURE WHICH ONE. ESSURE CONFIRMATION TEST WAS DONE:- FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING, VAGINAL ITCHING, VAGINAL IRRITATION, BACTERIAL VAGINOSIS, TINEA CRURIS, MONILIASIS VAGINAL AND POLYCYSTIC OVARIAN SYNDROME. CONCOMITANT PRODUCTS INCLUDED FLUCONAZOLE FOR VAGINITIS AS WELL AS ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL), METRONIDAZOLE BENZOATE (FLAGYL) AND MICONAZOLE NITRATE (MONISTAT). ON (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED HAEMORRHAGE IN PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABORTION THREATENED (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CUSHING'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN / SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), RASH ("RASHES OR SKIN CONDITIONS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINL PAIN") AND SKIN DISORDER ("RASHES OR SKIN CONDITIONS"), WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UNDERWENT HOSPITALISATION ("HOSPITALIZATION"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY, REMOVAL OF ESSURE). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION, HAEMORRHAGE IN PREGNANCY, CUSHING'S SYNDROME, ABORTION THREATENED, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, VULVOVAGINAL PAIN, HYPERSENSITIVITY, RASH, WEIGHT INCREASED, ABDOMINAL PAIN LOWER AND HOSPITALISATION OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD WAS ON (B)(6) 2015 AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2015. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABORTION THREATENED, CUSHING'S SYNDROME, DEVICE BREAKAGE, DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, HAEMORRHAGE IN PREGNANCY, HOSPITALISATION, HYPERSENSITIVITY, PELVIC PAIN, RASH, SKIN DISORDER, UTERINE PERFORATION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ECTOPIC PREGNANCY POSITIVE PREGNANCY TEST BUT THEN HAD PERIOD. DATE(S) OF INSERTION: (B)(6) 2007 (DISCREPANCY NOTED). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-MAR-2022: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('THE PORTION OF THE ESSURE WAS LEFT IN THE RIGHT FALLOPIAN TUBE'), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY/ ECTOPIC PREGNANCY'), UTERINE PERFORATION ('UTERINE PERFORATION'), HAEMORRHAGE IN PREGNANCY ('EARLY PREGNANCY BLEEDING'), DEVICE DISLOCATION ('ESSURE DEVICE WAS NOTED TO BE ADHERE TO THE LEFT ABDOMINAL WALL/ESSURE WAS NOT IN PLACE IN THE LEFT FALLOPIAN TUBE'), CUSHING'S SYNDROME ('HORMONAL CHANGES DESCRIBE: CUSHION SYNDROME'), ABORTION THREATENED ('THREATENED ABORTION') AND GENITAL HAEMORRHAGE ('HEAVY ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED RENAL SURGERY. ESSURE CONFIRMATION TEST WAS DONE: ONE TUBE OCCLUDED BUT UNSURE WHICH ONE. ESSURE CONFIRMATION TEST WAS DONE:- FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING, VAGINAL ITCHING, VAGINAL IRRITATION, BACTERIAL VAGINOSIS, TINEA CRURIS, MONILIASIS VAGINAL AND POLYCYSTIC OVARIAN SYNDROME. CONCOMITANT PRODUCTS INCLUDED FLUCONAZOLE FOR VAGINITIS AS WELL AS ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL), METRONIDAZOLE BENZOATE (FLAGYL) AND MICONAZOLE NITRATE (MONISTAT). ON (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED HAEMORRHAGE IN PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABORTION THREATENED (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CUSHING'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN / SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), RASH ("RASHES OR SKIN CONDITIONS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINL PAIN") AND SKIN DISORDER ("RASHES OR SKIN CONDITIONS"), WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UNDERWENT HOSPITALISATION ("HOSPITALIZATION"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY, REMOVAL OF ESSURE). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, UTERINE PERFORATION, HAEMORRHAGE IN PREGNANCY, CUSHING'S SYNDROME, ABORTION THREATENED, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, VULVOVAGINAL PAIN, HYPERSENSITIVITY, RASH, WEIGHT INCREASED, ABDOMINAL PAIN LOWER AND HOSPITALISATION OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD WAS ON (B)(6) 2015 AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2015. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABORTION THREATENED, CUSHING'S SYNDROME, DEVICE BREAKAGE, DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, HAEMORRHAGE IN PREGNANCY, HOSPITALISATION, HYPERSENSITIVITY, PELVIC PAIN, RASH, SKIN DISORDER, UTERINE PERFORATION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ECTOPIC PREGNANCY POSITIVE PREGNANCY TEST BUT THEN HAD PERIOD. DATE(S) OF INSERTION: (B)(6) 2007 (DISCREPANCY NOTED). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-FEB-2022: MEDICAL RECORD RECEIVED. REPORTER ADDED. NEW EVENT S, "UTERINE PERFORATION" , "THE PORTION OF THE ESSURE WAS LEFT IN THE RIGHT FALLOPIAN TUB" AND "ESSURE DEVICE WAS NOTED TO BE ADHERE TO THE LEFT ABDOMINAL WALL/ESSURE WAS NOT IN PLACE IN THE LEFT FALLOPIAN TUBE" ADDED. SURGERY DETAILS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY/ ECTOPIC PREGNANCY'), HAEMORRHAGE IN PREGNANCY ('EARLY PREGNANCY BLEEDING'), ABORTION THREATENED ('THREATENED ABORTION'), GENITAL HAEMORRHAGE ('HEAVY ABNORMAL BLEEDING') AND CUSHING'S SYNDROME ('HORMONAL CHANGES DESCRIBE: CUSHION SYNDROME') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED RENAL SURGERY. ESSURE CONFIRMATION TEST WAS DONE:- ONE TUBE OCCLUDED BUT UNSURE WHICH ONE. ESSURE CONFIRMATION TEST WAS DONE:- FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING, VAGINAL ITCHING, VAGINAL IRRITATION, BACTERIAL VAGINOSIS, TINEA CRURIS, MONILIASIS VAGINAL AND POLYCYSTIC OVARIAN SYNDROME. CONCOMITANT PRODUCTS INCLUDED FLUCONAZOLE FOR VAGINITIS AS WELL AS ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL), METRONIDAZOLE BENZOATE (FLAGYL) AND MICONAZOLE NITRATE (MONISTAT). ON (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED HAEMORRHAGE IN PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABORTION THREATENED (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN / SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), CUSHING'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RASH ("RASHES OR SKIN CONDITIONS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINL PAIN") AND SKIN DISORDER ("RASHES OR SKIN CONDITIONS"), WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UNDERWENT HOSPITALISATION ("HOSPITALIZATION"). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, HAEMORRHAGE IN PREGNANCY, ABORTION THREATENED, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, VULVOVAGINAL PAIN, HYPERSENSITIVITY, CUSHING'S SYNDROME, RASH, WEIGHT INCREASED, ABDOMINAL PAIN LOWER AND HOSPITALISATION OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD WAS ON (B)(6) 2015 AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2015. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABORTION THREATENED, CUSHING'S SYNDROME, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, HAEMORRHAGE IN PREGNANCY, HOSPITALISATION, HYPERSENSITIVITY, PELVIC PAIN, RASH, SKIN DISORDER, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ECTOPIC PREGNANCY POSITIVE PREGNANCY TEST BUT THEN HAD PERIOD. DATE(S) OF INSERTION: (B)(6) 2007 (DISCREPANCY NOTED). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUL-2020: PIF RECEIVED. NEW EVENT HOSPITALIZATION NOS WAS ADDED. ESSURE IMPLANT DATE WAS UPDATED AND EXPLANT DATE WAS ADDED. RCC WAS UPDATED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/ ECTOPIC PREGNANCY"), HAEMORRHAGE IN PREGNANCY ("EARLY PREGNANCY BLEEDING"), ABORTION THREATENED ("THREATENED ABORTION"), GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") AND CUSHING'S SYNDROME ("HORMONAL CHANGES DESCRIBE: CUSHION SYNDROME") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED RENAL SURGERY. ESSURE CONFIRMATION TEST WAS DONE: ONE TUBE OCCLUDED BUT UNSURE WHICH ONE. CONCURRENT CONDITIONS INCLUDED VAGINAL BLEEDING, VAGINAL ITCHING, VAGINAL IRRITATION, BACTERIAL VAGINOSIS, TINEA CRURIS, MONILIASIS VAGINAL AND POLYCYSTIC OVARIAN SYNDROME. CONCOMITANT PRODUCTS INCLUDED FLUCONAZOLE FOR VAGINITIS AS WELL AS ETHINYLESTRADIOL;NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL), METRONIDAZOLE BENZOATE (FLAGYL) AND MICONAZOLE NITRATE (MONISTAT). IN (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED HAEMORRHAGE IN PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABORTION THREATENED (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN / SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), CUSHING'S SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RASH ("RASHES OR SKIN CONDITIONS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND SKIN DISORDER ("RASHES OR SKIN CONDITIONS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, HAEMORRHAGE IN PREGNANCY, ABORTION THREATENED, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, VULVOVAGINAL PAIN, HYPERSENSITIVITY, CUSHING'S SYNDROME, RASH, WEIGHT INCREASED AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD WAS ON (B)(6) 2015 AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2015. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABORTION THREATENED, CUSHING'S SYNDROME, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, HAEMORRHAGE IN PREGNANCY, HYPERSENSITIVITY, PELVIC PAIN, RASH, SKIN DISORDER, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ECTOPIC PREGNANCY POSITIVE PREGNANCY TEST BUT THEN HAD PERIOD. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: EVENT FROM PFS: EVENT "PREGNANCY" WAS CLUBBED WITH "ECTOPIC PREGNANCY". PREGNANCY OUTCOME UPDATED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 |
|---|---|---|---|---|---|---|---|
| 230359 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Female | Required Intervention| O | FLAGYL [METRONIDAZOLE BENZOATE]| FLAGYL [METRONIDAZOLE BENZOATE]| FLAGYL [METRONIDAZOLE BENZOATE]| FLAGYL [METRONIDAZOLE BENZOATE]| FLUCONAZOLE| FLUCONAZOLE| FLUCONAZOLE| FLUCONAZOLE| MONISTAT| MONISTAT| MONISTAT| MONISTAT| NORGESTIMATE & ETHINYL ESTRADIOL| NORGESTIMATE & ETHINYL ESTRADIOL| NORGESTIMATE & ETHINYL ESTRADIOL| NORGESTIMATE & ETHINYL ESTRADIOL| FLAGYL [METRONIDAZOLE BENZOATE]| FLUCONAZOLE| MONISTAT| NORGESTIMATE & ETHINYL ESTRADIOL |