ESSURE
Report
- Report Number
- 2951250-2018-04295
- Event Type
- Injury
- Date Received
- October 12, 2018
- Date of Event
- March 1, 2013
- Report Date
- December 29, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PUNCTURED THE FALLLOPIAN TUBE") AND GENITAL HAEMORRHAGE ("UNUSUAL BLEEDING RESULTING FROM THE USE OF ESSURE") IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ERROR "DURING PROCEDURE,THE ESSURE® DEVICE MALFUNCTIONED IN THAT ONE NICKEL COIL BENT/ ESSURE PLACEMENT THERE WAS A COIL DEFECT WITH THE SECOND COIL" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGONE ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED LIVE BIRTH (PLAINTIFF STATES DOCTORS HAD TO USE FORCEPS DURING BIRTH BECAUSE TAILBONE WAS PREVENTING DAUGHTER FROM COMING OUT) ON (B)(6) 2013. CONCOMITANT PRODUCTS INCLUDED CAFFEINE;PARACETAMOL (EXCEDRIN ASPIRIN FREE). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("DURING PROCEDURE,THE ESSURE® DEVICE MALFUNCTIONED IN THAT ONE NICKEL COIL BENT/ IMPLANT FAILURE ON (B)(6) 2012"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN LOWER ("CRAMPING"), MIGRAINE ("MIGRAINES") AND MENSTRUATION IRREGULAR ("UNUSUAL PERIODS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN") AND HEADACHE ("HEAD PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, MENOMETRORRHAGIA ("IRREGULAR AND HEAVY MENSTRUAL CYCLES") AND ABDOMINAL DISTENSION ("BLOATING"). THE PATIENT WAS TREATED WITH CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3) AND IBUPROFEN. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, COMPLICATION OF DEVICE INSERTION, MENOMETRORRHAGIA, ABDOMINAL DISTENSION, DYSPAREUNIA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, MIGRAINE, MENSTRUATION IRREGULAR AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, COMPLICATION OF DEVICE INSERTION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, MENOMETRORRHAGIA, MENSTRUATION IRREGULAR AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF STATES SHE UNDERWENT AN ULTRASOUND AND COULD NOT GET THE DIE TEST BECAUSE SHE ONLY HAD ONE ESSURE DEVICE IMPLANTED. HER SYMPTOMS ARE SO SEVERE AND PROBLEMATIC THAT SHE IS DISCUSSING WITH HER DOCTOR REMOVAL OF THE ESSURE DEVICE. UPON PLACEMENT OF L COIL,4 TRAILING COILS IDENTIFIED BUT PORTION OF INSERTION IDENTIFIED IN THE MIDDLE OF THE COILS. COILS REMOVED AS WELL. SECOND COIL NOT PLACED PLAINTIFF STATES THAT THE LEFT SIDE WAS REMOVED DURING THE INSERTION OF ESSURE DEVICE ON (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON AN UNKNOWN DATE: UNDERWENT AN ULTRASOUND AND COULD NOT GET THE DIE TEST BECAUSE SHE ONLY HAD ONE ESSURE DEVICE IMPLANTED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PLAINTIFF FACT SHEET RECEIVED. EVENT COMPLICATION OF DEVICE INSERTION WAS CLUBBED WITH IMPLANT FAILURE ON 30MAR2012. EVENT: PATIENT DID NOT UNDERGONE ESSURE CONFIRMATION TEST WAS NEWLY 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PUNCTURED THE FALLLOPIAN TUBE') AND GENITAL HAEMORRHAGE ('UNUSUAL BLEEDING RESULTING FROM THE USE OF ESSURE') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) 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" ON (B)(6) 2013, DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGONE ESSURE CONFIRMATION TEST" AND DEVICE USE ERROR "DURING PROCEDURE,THE ESSURE® DEVICE MALFUNCTIONED IN THAT ONE NICKEL COIL BENT/ ESSURE PLACEMENT THERE WAS A COIL DEFECT WITH THE SECOND COIL". THE PATIENT'S MEDICAL HISTORY INCLUDED LIVE BIRTH (PLAINTIFF STATES DOCTORS HAD TO USE FORCEPS DURING BIRTH BECAUSE TAILBONE WAS PREVENTING DAUGHTER FROM COMING OUT) ON (B)(6) 2013, URINARY TRACT INFECTION, VOMITING, DYSURIA, DIARRHEA, BLOATING AND DYSMENORRHEA. CONCOMITANT PRODUCTS INCLUDED CAFFEINE;PARACETAMOL (EXCEDRIN ASPIRIN FREE). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("DURING PROCEDURE,THE ESSURE® DEVICE MALFUNCTIONED IN THAT ONE NICKEL COIL BENT/ IMPLANT FAILURE ON (B)(6) 2012"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN LOWER ("CRAMPING/CRAMPING"), MIGRAINE ("MIGRAINES") AND MENSTRUATION IRREGULAR ("UNUSUAL PERIODS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN/ABDOMINAL PAIN") AND HEADACHE ("HEAD PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, MENOMETRORRHAGIA ("IRREGULAR AND HEAVY MENSTRUAL CYCLES") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("SIX WEEKS ONE-DAY VIABLE INTRAUTERINE GESTATION"). THE PATIENT WAS TREATED WITH IBUPROFEN AND PARACETAMOL (TYLENOL). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, COMPLICATION OF DEVICE INSERTION, MENOMETRORRHAGIA, ABDOMINAL DISTENSION, DYSPAREUNIA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, MIGRAINE, MENSTRUATION IRREGULAR AND HEADACHE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE VAGINAL DELIVERY OCCURRED ON (B)(6) 2013. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, COMPLICATION OF DEVICE INSERTION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, MENOMETRORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF STATES SHE UNDERWENT AN ULTRASOUND AND COULD NOT GET THE DIE TEST BECAUSE SHE ONLY HAD ONE ESSURE DEVICE IMPLANTED. HER SYMPTOMS ARE SO SEVERE AND PROBLEMATIC THAT SHE IS DISCUSSING WITH HER DOCTOR REMOVAL OF THE ESSURE DEVICE. UPON PLACEMENT OF L COIL,4 TRAILING COILS IDENTIFIED BUT PORTION OF INSERTION IDENTIFIED IN THE MIDDLE OF THE COILS. COILS REMOVED AS WELL. SECOND COIL NOT PLACED PLAINTIFF STATES THAT THE LEFT SIDE WAS REMOVED DURING THE INSERTION OF ESSURE DEVICE ON (B)(6) 2012. TRAILING COILS: RIGHT 4. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON AN UNKNOWN DATE: UNDERWENT AN ULTRASOUND AND COULD NOT GET THE DIE TEST BECAUSE SHE ONLY HAD ONE ESSURE DEVICE IMPLANTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD ; ABDOMINAL PAIN, DYSPAREUNIA, HEADACHE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-DEC-2020: MEDICAL RECORD RECEIVED EVENT "SIX WEEKS ONE-DAY VIABLE INTRAUTERINE GESTATION" WAS ADDED. REPORTER INFORMATION, MEDICAL HISTORY 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
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PUNCTURED THE FALLOPIAN TUBE') AND GENITAL HAEMORRHAGE ('UNUSUAL BLEEDING RESULTING FROM THE USE OF ESSURE') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" ON (B)(6) 2013, DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGONE ESSURE CONFIRMATION TEST" AND DEVICE USE ERROR "DURING PROCEDURE,THE ESSURE® DEVICE MALFUNCTIONED IN THAT ONE NICKEL COIL BENT/ ESSURE PLACEMENT THERE WAS A COIL DEFECT WITH THE SECOND COIL". THE PATIENT'S MEDICAL HISTORY INCLUDED LIVE BIRTH (PLAINTIFF STATES DOCTORS HAD TO USE FORCEPS DURING BIRTH BECAUSE TAILBONE WAS PREVENTING DAUGHTER FROM COMING OUT) ON (B)(6) 2013, URINARY TRACT INFECTION, VOMITING, DYSURIA, DIARRHEA, BLOATING AND DYSMENORRHEA. CONCOMITANT PRODUCTS INCLUDED CAFFEINE;PARACETAMOL (EXCEDRIN ASPIRIN FREE). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION ("DURING PROCEDURE,THE ESSURE® DEVICE MALFUNCTIONED IN THAT ONE NICKEL COIL BENT/ IMPLANT FAILURE ON (B)(6) 2012"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN LOWER ("CRAMPING/CRAMPING"), MIGRAINE ("MIGRAINES") AND MENSTRUATION IRREGULAR ("UNUSUAL PERIODS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN/ABDOMINAL PAIN") AND HEADACHE ("HEAD PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, MENOMETRORRHAGIA ("IRREGULAR AND HEAVY MENSTRUAL CYCLES") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("SIX WEEKS ONE-DAY VIABLE INTRAUTERINE GESTATION"). THE PATIENT WAS TREATED WITH IBUPROFEN AND PARACETAMOL (TYLENOL). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, COMPLICATION OF DEVICE INSERTION, MENOMETRORRHAGIA, ABDOMINAL DISTENSION, DYSPAREUNIA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, MIGRAINE, MENSTRUATION IRREGULAR AND HEADACHE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE VAGINAL DELIVERY OCCURRED ON (B)(6) 2013. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, COMPLICATION OF DEVICE INSERTION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HEMORRHAGE, HEADACHE, MENOMETRORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: PLAINTIFF STATES SHE UNDERWENT AN ULTRASOUND AND COULD NOT GET THE DIE TEST BECAUSE SHE ONLY HAD ONE ESSURE DEVICE IMPLANTED. HER SYMPTOMS ARE SO SEVERE AND PROBLEMATIC THAT SHE IS DISCUSSING WITH HER DOCTOR REMOVAL OF THE ESSURE DEVICE. UPON PLACEMENT OF L COIL,4 TRAILING COILS IDENTIFIED BUT PORTION OF INSERTION IDENTIFIED IN THE MIDDLE OF THE COILS. COILS REMOVED AS WELL. SECOND COIL NOT PLACED PLAINTIFF STATES THAT THE LEFT SIDE WAS REMOVED DURING THE INSERTION OF ESSURE DEVICE ON (B)(6) 2012. TRAILING COILS: RIGHT 4. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON AN UNKNOWN DATE: UNDERWENT AN ULTRASOUND AND COULD NOT GET THE DIE TEST BECAUSE SHE ONLY HAD ONE ESSURE DEVICE IMPLANTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD ; ABDOMINAL PAIN, DYSPAREUNIA, HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-DEC-2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). WE RECEIVED A LOT NUMBER IN THIS CASE. 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 FALLOPIAN TUBE PERFORATION ("PUNCTURED THE FALLOPIAN TUBE") AND GENITAL HAEMORRHAGE ("UNUSUAL BLEEDING RESULTING FROM THE USE OF ESSURE") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ERROR. "RING PROCEDURE,THE ESSURE® DEVICE MALFUNCTIONED IN THAT ONE NICKEL COIL BENT/ESSURE PLACEMENT THERE WAS A COIL DEFECT WITH THE SECOND COIL". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND MENSTRUATION IRREGULAR ("UNUSUAL PERIODS"). IN 2013, THE PATIENT EXPERIENCED HEADACHE ("HEAD PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, COMPLICATION OF DEVICE INSERTION ("DURING PROCEDURE,THE ESSURE® DEVICE MALFUNCTIONED IN THAT ONE NICKEL COIL BENT"), MENOMETRORRHAGIA ("IRREGULAR AND HEAVY MENSTRUAL CYCLES"), ABDOMINAL DISTENSION ("BLOATING"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING") AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SOLPADEINE (TYLENOL 1) AND IBUPROFEN. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, COMPLICATION OF DEVICE INSERTION, MENOMETRORRHAGIA, ABDOMINAL DISTENSION, DYSPAREUNIA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, MIGRAINE, GENITAL HAEMORRHAGE, MENSTRUATION IRREGULAR AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, COMPLICATION OF DEVICE INSERTION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, MENOMETRORRHAGIA, MENSTRUATION IRREGULAR AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF STATES SHE UNDERWENT AN ULTRASOUND AND COULD NOT GET THE DIE TEST BECAUSE SHE ONLY HAD ONE ESSURE DEVICE IMPLANTED. HER SYMPTOMS ARE SO SEVERE AND PROBLEMATIC THAT SHE IS DISCUSSING WITH HER DOCTOR REMOVAL OF THE ESSURE DEVICE. UPON PLACEMENT OF L COIL,4 TRAILING COILS IDENTIFIED BUT PORTION OF INSERTION IDENTIFIED IN THE MIDDLE OF THE COILS. COILS REMOVED AS WELL. SECOND COIL NOT PLACED. DIAGNOSTIC RESULTS: ON UNKNOWN DATE: PLAINTIFF STATES SHE UNDERWENT AN ULTRASOUND AND COULD NOT GET THE DIE TEST BECAUSE SHE ONLY HAD ONE ESSURE DEVICE IMPLANTED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-OCT-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 802247 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922613 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other | EXCEDRIN ASPIRIN FREE| EXCEDRIN ASPIRIN FREE| EXCEDRIN ASPIRIN FREE |