ESSURE
Report
- Report Number
- 2951250-2017-08833
- Event Type
- Injury
- Date Received
- November 24, 2017
- Date of Event
- June 4, 2010
- Report Date
- August 3, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE CORNUA"), PELVIC PAIN ("CHRONIC PELVIC PAIN/PAIN,") AND INTRA-ABDOMINAL HAEMORRHAGE ("SEVERE ABDOMINAL BLEEDING") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 686080) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HERNIA, MULTI GRAVIDA AND PARITY 5. CONCURRENT CONDITIONS INCLUDED PITUITARY ADENOMA, CUSHING'S DISEASE, UTERINE FIBROIDS, WEIGHT GAIN, ANXIETY, DEPRESSION, CHANGE IN SLEEP PATTERN AND UTI. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D3) FROM 2015 TO 2017, IBUPROFEN FROM 2015 TO 2017 AND STEROID ANTIBACTERIALS FROM 2013 TO 2017. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING/PAIN,"). IN 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). IN 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DERMATITIS ("RASHES OR SKIN CONDITIONS TYPE: FACE DERMATITIS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRA-ABDOMINAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF PAIN IN EXTREMITY ("LEG PAIN"), ARTHRALGIA ("JOINT PAIN"), RASH ("RASH ON FACE") AND THE SECOND EPISODE OF PAIN IN EXTREMITY ("HAND PAIN/FINGER PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN/PAIN,"). THE PATIENT WAS TREATED WITH SURGERY (OPERATIVE LAPAROSCOPY WITH BILATERAL FALLOPIAN TUBE REMOVALS WITH CORNEAL UTERINE RESECTION) AND SURGERY (OPERATIVE LAPAROSCOPY WITH BILATERAL FALLOPIAN TUBE REMOVALS WITH CORNEAL UTERINE RESECTION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, INTRA-ABDOMINAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, FATIGUE, DYSPAREUNIA, ALLERGY TO METALS, DYSMENORRHOEA, ALOPECIA, ARTHRALGIA, RASH AND THE LAST EPISODE OF PAIN IN EXTREMITY OUTCOME WAS UNKNOWN, THE PELVIC PAIN, ABDOMINAL PAIN AND DERMATITIS WAS RESOLVING AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, DERMATITIS, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, INTRA-ABDOMINAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, RASH, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF PAIN IN EXTREMITY AND THE SECOND EPISODE OF PAIN IN EXTREMITY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE LATERAL TUBAL OSTIA VISUALIZED AND CANNULATED. THE LEFT SIDE WITH 1 COIL SHOWING RIGHT SIDE WITH 2 COIL SHOWING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2013: ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES CT-ABDOMEN W/IV CONTRAST: IMPRESSION: NO ACUTE INTRA-ABDOMINAL ABNORMALITY. THERE IS NO CHANGE THE APPEARANCE OF THE MESH ABDOMINAL HERNIA REPAIR, HOWEVER SOME QUESTION MAY BE RAISED AS TO THE INTEGRITY OF THE LEFT SIDE OF THE MESH. THE PATIENT STATES THAT SHE HAD NOT HAD A MENSTRUAL PERIOD SINCE HER TRANSSPHENOIDAL PITUITARY SURGERY IN THE SPRINGTIME. CT EARLIER THIS YEAR WHICH SHOWED HEPATOMEGALY (MILD). CT SCAN OF ABDOMEN "NOTHING BUT A UTI. ESSURE CONFIRMATION TEST ON (B)(6) 2012 AND (B)(6) 2016 (PER PFS) TYPE OF TEST: HYSTEROSALPINGOGRAM (HSG) RESULTS OF ESSURE CONFIRMATION TEST: TOTAL BILATERAL OCCLUSION . CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS AND SOCIAL MEDIA:NICKEL ALLERGY, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FACE DERMATITIS.PAIN IN EXTREMITY, JOINT PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUL-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE CORNUA"), PELVIC PAIN ("CHRONIC PELVIC PAIN/PAIN,") AND INTRA-ABDOMINAL HAEMORRHAGE ("SEVERE ABDOMINAL BLEEDING") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 686080) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HERNIA, MULTI GRAVIDA AND PARITY 5. CONCURRENT CONDITIONS INCLUDED PITUITARY ADENOMA, CUSHING'S DISEASE, UTERINE FIBROIDS, WEIGHT GAIN, ANXIETY, DEPRESSION, CHANGE IN SLEEP PATTERN AND UTI. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D3) FROM 2015 TO 2017, IBUPROFEN FROM 2015 TO 2017 AND STEROID ANTIBACTERIALS FROM 2013 TO 2017. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING/PAIN,"). IN 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). IN 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DERMATITIS ("RASHES OR SKIN CONDITIONS TYPE: FACE DERMATITIS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRA-ABDOMINAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN/PAIN,"). THE PATIENT WAS TREATED WITH SURGERY (OPERATIVE LAPAROSCOPY WITH BILATERAL FALLOPIAN TUBE REMOVALS WITH CORNEAL UTERINE RESECTION) AND SURGERY (OPERATIVE LAPAROSCOPY WITH BILATERAL FALLOPIAN TUBE REMOVALS WITH CORNEAL UTERINE RESECTION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, INTRA-ABDOMINAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, FATIGUE, DYSPAREUNIA, ALLERGY TO METALS, DYSMENORRHOEA AND ALOPECIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN, ABDOMINAL PAIN AND DERMATITIS WAS RESOLVING AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, DERMATITIS, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, INTRA-ABDOMINAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE LATERAL TUBAL OSTIA VISUALIZED AND CANNULATED. THE LEFT SIDE WITH 1 COIL SHOWING RIGHT SIDE WITH 2 COIL SHOWING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2013: ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES CT-ABDOMEN W/IV CONTRAST: IMPRESSION: NO ACUTE INTRA-ABDOMINAL ABNORMALITY. THERE IS NO CHANGE THE APPEARANCE OF THE MESH ABDOMINAL HERNIA REPAIR, HOWEVER SOME QUESTION MAY BE RAISED AS TO THE INTEGRITY OF THE LEFT SIDE OF THE MESH. THE PATIENT STATES THAT SHE HAD NOT HAD A MENSTRUAL PERIOD SINCE HER TRANSSPHENOIDAL PITUITARY SURGERY IN THE SPRINGTIME. CT EARLIER THIS YEAR WHICH SHOWED HEPATOMEGALY (MILD). CT SCAN OF ABDOMEN "NOTHING BUT A UTI. ESSURE CONFIRMATION TEST ON (B)(6) 2012 AND (B)(6) 2016 (PER PFS) TYPE OF TEST: HYSTEROSALPINGOGRAM (HSG) RESULTS OF ESSURE CONFIRMATION TEST: TOTAL BILATERAL OCCLUSION. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS NICKEL ALLERGY, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FACE DERMATITIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED: REPORTERS DETAILS ADDED. EVENT ADDED AS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), RASHES OR SKIN CONDITIONS TYPE: FACE DERMATITIS, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE CORNUA, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, HAIR LOSS LOT NUMBER ADDED. CASE MEDICALLY CONFIRMED. HISTORICAL, CONCOMITANT CONDITION AND RELEVANT LAB DATA WERE ADDED. CONCOMITANT, HISTORICAL DRUGS AND TREATMENT DRUGS WERE ADDED. INCIDENT~ AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE CORNUA"), PELVIC PAIN ("CHRONIC PELVIC PAIN/PAIN,") AND INTRA-ABDOMINAL HAEMORRHAGE ("SEVERE ABDOMINAL BLEEDING") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 686080) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HERNIA, MULTI GRAVIDA AND PARITY 5. CONCURRENT CONDITIONS INCLUDED PITUITARY ADENOMA, CUSHING'S DISEASE, UTERINE FIBROIDS, WEIGHT GAIN, ANXIETY, DEPRESSION, CHANGE IN SLEEP PATTERN AND UTI. CONCOMITANT PRODUCTS INCLUDED CHOLECALCIFEROL (VITAMIN D3) FROM 2015 TO 2017, IBUPROFEN FROM 2015 TO 2017 AND STEROID ANTIBACTERIALS FROM 2013 TO 2017. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING/PAIN,"). IN 2010, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). IN 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DERMATITIS ("RASHES OR SKIN CONDITIONS TYPE: FACE DERMATITIS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTRA-ABDOMINAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF PAIN IN EXTREMITY ("LEG PAIN"), ARTHRALGIA ("JOINT PAIN"), RASH ("RASH ON FACE") AND THE SECOND EPISODE OF PAIN IN EXTREMITY ("HAND PAIN/FINGER PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN/PAIN,"). THE PATIENT WAS TREATED WITH SURGERY (OPERATIVE LAPAROSCOPY WITH BILATERAL FALLOPIAN TUBE REMOVALS WITH CORNEAL UTERINE RESECTION) AND SURGERY (OPERATIVE LAPAROSCOPY WITH BILATERAL FALLOPIAN TUBE REMOVALS WITH CORNEAL UTERINE RESECTION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, INTRA-ABDOMINAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, FATIGUE, DYSPAREUNIA, ALLERGY TO METALS, DYSMENORRHOEA, ALOPECIA, ARTHRALGIA, RASH AND THE LAST EPISODE OF PAIN IN EXTREMITY OUTCOME WAS UNKNOWN, THE PELVIC PAIN, ABDOMINAL PAIN AND DERMATITIS WAS RESOLVING AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, DERMATITIS, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, INTRA-ABDOMINAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, RASH, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF PAIN IN EXTREMITY AND THE SECOND EPISODE OF PAIN IN EXTREMITY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE LATERAL TUBAL OSTIA VISUALIZED AND CANNULATED. THE LEFT SIDE WITH 1 COIL SHOWING RIGHT SIDE WITH 2 COIL SHOWING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2013: ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES CT-ABDOMEN W/IV CONTRAST: IMPRESSION: NO ACUTE INTRA-ABDOMINAL ABNORMALITY. THERE IS NO CHANGE THE APPEARANCE OF THE MESH ABDOMINAL HERNIA REPAIR, HOWEVER SOME QUESTION MAY BE RAISED AS TO THE INTEGRITY OF THE LEFT SIDE OF THE MESH. THE PATIENT STATES THAT SHE HAD NOT HAD A MENSTRUAL PERIOD SINCE HER TRANSSPHENOIDAL PITUITARY SURGERY IN THE SPRINGTIME. CT EARLIER THIS YEAR WHICH SHOWED HEPATOMEGALY (MILD). CT SCAN OF ABDOMEN "NOTHING BUT A UTI. ESSURE CONFIRMATION TEST ON (B)(6) 2012 AND (B)(6) 2016 (PER PFS) TYPE OF TEST: HYSTEROSALPINGOGRAM (HSG) RESULTS OF ESSURE CONFIRMATION TEST: TOTAL BILATERAL OCCLUSION CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS AND SOCIAL MEDIA:NICKEL ALLERGY, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FACE DERMATITIS. PAIN IN EXTREMITY, JOINT PAIN MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: SOCIAL MEDIA RECEIVED:THE EVENT:PAIN IN EXTREMITY, JOINT PAIN ADDED. INCIDENT~ AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") AND INTRA-ABDOMINAL HAEMORRHAGE ("SEVERE ABDOMINAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6), THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), INTRA-ABDOMINAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), FATIGUE ("FATIGUE") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6), SHE UNDERWENT A PELVIC SURGERY TO TRY AND ALLEVIATE THE SYMPTOMS). AT THE TIME OF THE REPORT, THE PELVIC PAIN, INTRA-ABDOMINAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, FATIGUE AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSPAREUNIA, FATIGUE, INTRA-ABDOMINAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6): ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES 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 |
|---|---|---|---|---|---|---|---|
| 837020 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 686080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other| R | IBUPROFEN| IBUPROFEN| IBUPROFEN| STEROID ANTIBACTERIALS| STEROID ANTIBACTERIALS| STEROID ANTIBACTERIALS| VITAMIN D3| VITAMIN D3| VITAMIN D3 |