ESSURE
Report
- Report Number
- 2951250-2017-05982
- Event Type
- Injury
- Date Received
- November 3, 2017
- Date of Event
- March 1, 2012
- Report Date
- August 2, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880429) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CHLAMYDIAL INFECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MICRONOR FROM 31-AUG-2011 TO 15-NOV-2011. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MISOPROSTOL, OXYCOCET (ACETAMINOPHEN W/OXYCODONE), TYLOX (PERCOCET [OXYCODONE HYDROCHLORIDE,OXYCODONE TEREPHTHALATE,PARACETAMOL]), VICODIN (LORTAB) AND GENERIC PNV. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 3 MONTHS 18 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/ABNORMAL BLEEDING (MENORRHAGIA)"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), THE FIRST EPISODE OF DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ALOPECIA ("HAIR LOSS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS") AND WEIGHT FLUCTUATION ("WEIGHT GAIN/WEIGHT LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN, EVEN WHEN NOT MENSTRUATING"), MOOD SWINGS ("MOOD SWINGS"), HEADACHE ("WORSENING OF HER HEADACHES"), THE SECOND EPISODE OF DYSPAREUNIA ("PAINFUL INTERCOURSE"), RASH ("RASH"), PRURITUS ("ITCHING"), FATIGUE ("CHRONIC FATIGUE"), WEIGHT DECREASED ("WEIGHT LOSS") AND ABDOMINAL PAIN ("ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, MENORRHAGIA, MOOD SWINGS, HEADACHE, THE LAST EPISODE OF DYSPAREUNIA, RASH, PRURITUS, FATIGUE, WEIGHT DECREASED, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, ALOPECIA, NERVOUS SYSTEM DISORDER, ABDOMINAL PAIN AND WEIGHT FLUCTUATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MOOD SWINGS, NERVOUS SYSTEM DISORDER, PELVIC PAIN, PRURITUS, RASH, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, WEIGHT FLUCTUATION, THE FIRST EPISODE OF DYSPAREUNIA AND THE SECOND EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, PLAINTIFF SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. FURTHERMORE, DUE TO THE SYMPTOMS AND TREATMENTS ENDURED BY PLAINTIFF AS A RESULT OF HER IMPLANTATION OF ESSURE, SHE HAS BEEN FORCED TO MISS TIME FROM WORK. PFS- PATIENT SAID THAT THINGS GOT BETTER AFTER REMOVAL BUT THERE ARE STILL SOME UNRESOLVED ISSUES. IT DID TAKE TIME FOR HER BODY TO ADJUST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PLAINTIFF FACT SHEET RECEIVED: EVENTS PER PFS: ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) ,NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: TO BE SUPPLEMENTED, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), HAIR LOSS, PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST, WEIGHT GAIN/WEIGHT LOSS WERE ADDED. LOT NUMBER RECEIVED. CONCOMITANT MEDICATIONS ADDED. HISTORY UPDATED. 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/PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880429) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CHLAMYDIAL INFECTION, AMENORRHEA, BREAST TENDERNESS, LIGHTHEADEDNESS, URINARY FREQUENCY AND PREGNANT. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MICRONOR FROM (B)(6) 2011 TO (B)(6) 2011. CONCURRENT CONDITIONS INCLUDED GONORRHEA, CHEST PAIN AND BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MISOPROSTOL, OXYCOCET (ACETAMINOPHEN W/OXYCODONE), OXYCOCET (PERCOCET), VICODIN (LORTAB) AND GENERIC PNV. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 3 MONTHS 18 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), THE FIRST EPISODE OF DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ALOPECIA ("HAIR LOSS"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS: MEMORY LOSS") AND WEIGHT DECREASED ("WEIGHT GAIN/WEIGHT LOSS/WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("CHRONIC FATIGUE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED RASH ("RASH") AND PRURITUS ("ITCHING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN, EVEN WHEN NOT MENSTRUATING"), MOOD SWINGS ("MOOD SWINGS"), HEADACHE ("WORSENING OF HER HEADACHES"), THE SECOND EPISODE OF DYSPAREUNIA ("PAINFUL INTERCOURSE") AND ABDOMINAL PAIN ("ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, MENORRHAGIA, MOOD SWINGS, HEADACHE, THE LAST EPISODE OF DYSPAREUNIA, VAGINAL HAEMORRHAGE, ALOPECIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN, THE RASH, PRURITUS, FATIGUE AND WEIGHT DECREASED HAD RESOLVED AND THE AMNESIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, AMNESIA, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PRURITUS, RASH, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, THE FIRST EPISODE OF DYSPAREUNIA AND THE SECOND EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, PLAINTIFF SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. FURTHERMORE, DUE TO THE SYMPTOMS AND TREATMENTS ENDURED BY PLAINTIFF AS A RESULT OF HER IMPLANTATION OF ESSURE, SHE HAS BEEN FORCED TO MISS TIME FROM WORK. PFS- PATIENT SAID THAT THINGS GOT BETTER AFTER REMOVAL BUT THERE ARE STILL SOME UNRESOLVED ISSUES. IT DID TAKE TIME FOR HER BODY TO ADJUST. TRAILING INTO THE UTERINE CAVITY WAS 3, COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 6. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 18.8 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; CONFIRMING- DYSMENORRHEA, DYSPAREUNIA, PELVIC PAIN." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL PROBLEM UPDATE. 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/PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880429) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CHLAMYDIAL INFECTION, AMENORRHEA, BREAST TENDERNESS, LIGHTHEADEDNESS, URINARY FREQUENCY AND PREGNANT. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MICRONOR FROM (B)(6) 2011 TO (B)(6) 2011. CONCURRENT CONDITIONS INCLUDED GONORRHEA, CHEST PAIN AND BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MISOPROSTOL, OXYCOCET (ACETAMINOPHEN W/OXYCODONE), OXYCOCET (PERCOCET), VICODIN (LORTAB) AND GENERIC PNV. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 3 MONTHS 18 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), THE FIRST EPISODE OF DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ALOPECIA ("HAIR LOSS"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS: MEMORY LOSS") AND WEIGHT DECREASED ("WEIGHT GAIN/WEIGHT LOSS/WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("CHRONIC FATIGUE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED RASH ("RASH") AND PRURITUS ("ITCHING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN, EVEN WHEN NOT MENSTRUATING"), MOOD SWINGS ("MOOD SWINGS"), HEADACHE ("WORSENING OF HER HEADACHES"), THE SECOND EPISODE OF DYSPAREUNIA ("PAINFUL INTERCOURSE") AND ABDOMINAL PAIN ("ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, MENORRHAGIA, MOOD SWINGS, HEADACHE, THE LAST EPISODE OF DYSPAREUNIA, VAGINAL HAEMORRHAGE, ALOPECIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN, THE RASH, PRURITUS, FATIGUE AND WEIGHT DECREASED HAD RESOLVED AND THE AMNESIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, AMNESIA, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PRURITUS, RASH, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, THE FIRST EPISODE OF DYSPAREUNIA AND THE SECOND EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, PLAINTIFF SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. FURTHERMORE, DUE TO THE SYMPTOMS AND TREATMENTS ENDURED BY PLAINTIFF AS A RESULT OF HER IMPLANTATION OF ESSURE, SHE HAS BEEN FORCED TO MISS TIME FROM WORK. PFS- PATIENT SAID THAT THINGS GOT BETTER AFTER REMOVAL BUT THERE ARE STILL SOME UNRESOLVED ISSUES. IT DID TAKE TIME FOR HER BODY TO ADJUST. TRAILING INTO THE UTERINE CAVITY WAS 3, COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 6. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 18.8 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; CONFIRMING- DYSMENORRHEA, DYSPAREUNIA, PELVIC PAIN." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-JUN-2018: PFS RECEIVED- WEIGHT GAIN/WEIGHT LOSS WAS UPDATED TO WEIGHT LOSS AND EVENT NEUROLOGICAL CONDITIONS OR PROBLEMS WAS UPDATED TO MEMORY LOSS. CONCOMITANT CONDITION WERE ADDED. OUTCOME OF EVENT MEMORY LOSS, FATIGUE, WEIGHT LOSS, RASH AND ITCHING 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 PELVIC PAIN ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING / LOWER ABDOMINAL PAIN, EVEN WHEN NOT MENSTRUATING"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING"), MOOD SWINGS ("MOOD SWINGS"), HEADACHE ("WORSENING OF HER HEADACHES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), RASH ("RASH"), PRURITUS ("ITCHING"), FATIGUE ("CHRONIC FATIGUE") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, MENORRHAGIA, MOOD SWINGS, HEADACHE, DYSPAREUNIA, RASH, PRURITUS, FATIGUE AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PRURITUS, RASH AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HER REMOVAL SURGERY, PLAINTIFF SYMPTOMS HAVE MOSTLY RESOLVED, THOUGH SOME REMAIN. FURTHERMORE, DUE TO THE SYMPTOMS AND TREATMENTS ENDURED BY PLAINTIFF AS A RESULT OF HER IMPLANTATION OF ESSURE, SHE HAS BEEN FORCED TO MISS TIME FROM WORK. 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 |
|---|---|---|---|---|---|---|---|
| 779623 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880429 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | ACETAMINOPHEN W/OXYCODONE| ACETAMINOPHEN W/OXYCODONE| ACETAMINOPHEN W/OXYCODONE| IBUPROFEN| IBUPROFEN| IBUPROFEN| LORTAB| LORTAB| LORTAB| MISOPROSTOL| MISOPROSTOL| MISOPROSTOL| PERCOCET| PERCOCET| PERCOCET| UNCODEABLE "UNCLASSIFIABLE"| UNCODEABLE "UNCLASSIFIABLE"| UNCODEABLE "UNCLASSIFIABLE" |