ESSURE
Report
- Report Number
- 2951250-2017-04621
- Event Type
- Injury
- Date Received
- October 12, 2017
- Report Date
- February 4, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 20227511, 20224430) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, NAUSEA AND HAIR LOSS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE/ LAPAROSCOPIC HYS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE MENSTRUAL DISORDER, WEIGHT INCREASED, DEPRESSION, ANXIETY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE DEVICE WAS PLACED WITHIN THE RIGHT TUBAL OSTIUM UNDER DIRECT VISUALIZATION. HOWEVER, THE DEVICE ONLY PARTIALLY DEPLOYED AND DID NOT FULLY DEPLOY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.2 KG/SQM. ON OR ABOUT JUNE 24, 2010 PLAINTIFF HAS AN HSG TEST DONE WHICH CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. BATCH NUMBER: 20224430 MAN DATE: NOV-2009, EXP DATE: NOV- 2012. BATCH NUMBER: 20227511 MAN DATE: DEC-2009 EXP DATE: DEC-2012. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-AUG-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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 20227511, 20224430) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, NAUSEA AND HAIR LOSS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE/ LAPAROSCOPIC HYS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE MENSTRUAL DISORDER, WEIGHT INCREASED, DEPRESSION, ANXIETY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE DEVICE WAS PLACED WITHIN THE RIGHT TUBAL OSTIUM UNDER DIRECT VISUALIZATION. HOWEVER, THE DEVICE ONLY PARTIALLY DEPLOYED AND DID NOT FULLY DEPLOY . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.2 KG/SQM. ON OR ABOUT (B)(6) 2010 PLAINTIFF HAS AN HSG TEST DONE WHICH CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUL-2018: PFS+MR RECEIVED: NEW EVENTS: VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA, WEIGHT INCREASED, REPORTER, PATIENT DEMOGRAPHIC INFORMATION, PRODUCT LOT NUMBER, CONCOMITANT DISEASE 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 ('SEVERE PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 20227511, 20224430) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MOTRIN FROM 2010 TO 2016. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, NAUSEA, HAIR LOSS AND KNEE ARTHRITIS. CONCOMITANT PRODUCTS INCLUDED DIPHENHYDRAMINE CITRATE;IBUPROFEN (MOTRIN PM), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ALOPECIA HAD RESOLVED AND THE MENSTRUAL DISORDER, WEIGHT INCREASED, DEPRESSION, ANXIETY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE DEVICE WAS PLACED WITHIN THE RIGHT TUBAL OSTIUM UNDER DIRECT VISUALIZATION. HOWEVER, THE DEVICE ONLY PARTIALLY DEPLOYED AND DID NOT FULLY DEPLOY. PATIENT RECEIVED TREATMENT FOR PAIN, ABNORMAL BLEEDING, HAIR LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: RESULTS:ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.. BATCH NUMBER: 20224430 MAN DATE: NOV-2009, EXP DATE: NOV- 2012. BATCH NUMBER: 20227511 MAN DATE: DEC-2009 EXP DATE: DEC-2012. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PFS RECEIVED. EVENT ADDED: HAIR LOSS. EVENT OUTCOME UPDATED TO RECOVERED/ RESOLVED FOR: PAIN, HAIR LOSS. 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 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 PELVIC PAIN ('SEVERE PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 20227511, 20224430) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MOTRIN FROM 2010 TO 2016. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, NAUSEA, HAIR LOSS AND KNEE ARTHRITIS. CONCOMITANT PRODUCTS INCLUDED DIPHENHYDRAMINE CITRATE; IBUPROFEN (MOTRIN PM), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ALOPECIA HAD RESOLVED AND THE MENSTRUAL DISORDER, WEIGHT INCREASED, DEPRESSION, ANXIETY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE DEVICE WAS PLACED WITHIN THE RIGHT TUBAL OSTIUM UNDER DIRECT VISUALIZATION. HOWEVER, THE DEVICE ONLY PARTIALLY DEPLOYED AND DID NOT FULLY DEPLOY. PATIENT RECEIVED TREATMENT FOR PAIN, ABNORMAL BLEEDING, HAIR LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: RESULTS:ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. LOT NUMBER: 20224430, MANUFACTURING DATE: 2009/11, EXPIRATION DATE: 2012/11. LOT NUMBER: 20227511, MANUFACTURING DATE: 2009/12, EXPIRATION DATE: 2012/12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-FEB-2021: QUALITY-SAFETY EVALUATION OF PTC. 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 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 PELVIC PAIN ('SEVERE PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 20227511, 20224430) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MOTRIN FROM 2010 TO 2016. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, NAUSEA, HAIR LOSS AND KNEE ARTHRITIS. CONCOMITANT PRODUCTS INCLUDED DIPHENHYDRAMINE CITRATE;IBUPROFEN (MOTRIN PM), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ALOPECIA HAD RESOLVED AND THE MENSTRUAL DISORDER, WEIGHT INCREASED, DEPRESSION, ANXIETY AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE DEVICE WAS PLACED WITHIN THE RIGHT TUBAL OSTIUM UNDER DIRECT VISUALIZATION. HOWEVER, THE DEVICE ONLY PARTIALLY DEPLOYED AND DID NOT FULLY DEPLOY. PATIENT RECEIVED TREATMENT FOR PAIN, ABNORMAL BLEEDING, HAIR LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: RESULTS:ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.. BATCH NUMBER: 20224430 MAN DATE: NOV-2009, EXP DATE: NOV- 2012. BATCH NUMBER: 20227511 MAN DATE: DEC-2009 EXP DATE: DEC-2012. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PFS RECEIVED. EVENT ADDED: HAIR LOSS. EVENT OUTCOME UPDATED TO RECOVERED/ RESOLVED FOR: PAIN, HAIR LOSS. 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 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 PELVIC PAIN ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: ON OR ABOUT (B)(6) 2010 PLAINTIFF HAS AN HSG TEST DONE WHICH CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. 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 |
|---|---|---|---|---|---|---|---|
| 723330 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 20227511, 20224430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| MOTRIN PM| MOTRIN PM| MOTRIN PM |