ESSURE
Report
- Report Number
- 2951250-2019-05119
- Event Type
- Injury
- Date Received
- August 27, 2019
- Date of Event
- September 1, 2011
- Report Date
- October 23, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/ PAIN') AND VAGINAL ABSCESS ('INFECTION (OTHER) DESCRIBE: ABSCESS ¿ VAGINAL CUFF') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRITIS, LEG PAIN, MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED DIABETES SINCE 2016, SKIN DISORDER SINCE 2016, ASTHMA SINCE 2009, INGUINAL HERNIA REPAIR, GASTRITIS, LIBIDO DECREASED, VAGINAL DRYNESS, ENDOMETRIOSIS, PELVIC MASS AND PELVIC ABSCESS. CONCOMITANT PRODUCTS INCLUDED NAPROXEN, PANTOPRAZOLE AND SALBUTAMOL (ALBUTEROL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHOEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI") AND MIGRAINE ("MIGRAINE/HEADACHE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL. DISCHARGE"), 3 MONTHS 14 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN,CHRONIC."), VAGINAL ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"), WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES ,OTHER") AND UNDERWENT HERNIA REPAIR ("HERNIA REPAIR"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2015- TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED); (B)(6) 2017- BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, CYSTITIS, VAGINAL INFECTION, URINARY TRACT INFECTION AND MIGRAINE HAD RESOLVED, THE DYSMENORRHOEA, ABDOMINAL PAIN, FATIGUE, HORMONE LEVEL ABNORMAL, HERNIA REPAIR, VAGINAL ABSCESS AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HERNIA REPAIR, HORMONE LEVEL ABNORMAL, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL ABSCESS, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TEST: BILATERAL OCCLUSION. ULTRASOUND SCAN VAGINA - ON (B)(6) 2011: NEGATIVE PELVIC ULTRASOUND. BILATERAL TUBAL OCCLUSION DEVICES NOTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS : ABDOMINAL PAIN LOWER, DYSMENORRHEA, PELVIC PAIN, DYSPAREUNIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-SEP-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED : LOT NUMBER ADDED. REPORTER INFORMATION, PATIENT DETAILS, PRODUCT INDICATION UPDATED. EVENTS ADDED- VAGINAL ABSCESS, ABDOMINAL PAIN LOWER, BACK PAIN. OUTCOME OF EVENTS ¿DYSPAREUNIA, VAGINAL DISCHARGE, VAGINAL INFECTION, CYSTITIS, URINARY TRACT INFECTION, MIGRAINE¿ UPDATED TO ¿RECOVERED / RESOLVED¿. MEDICAL HISTORY AND CONCOMITANT CONDITIONS ADDED. CONCOMITANT PRODUCTS ADDED. LAB DATA ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/ PAIN') AND VAGINAL ABSCESS ('INFECTION (OTHER) DESCRIBE: ABSCESS ¿ VAGINAL CUFF') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRITIS, LEG PAIN, MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED DIABETES SINCE 2016, SKIN DISORDER SINCE 2016, ASTHMA SINCE 2009, INGUINAL HERNIA REPAIR, GASTRITIS, LIBIDO DECREASED, VAGINAL DRYNESS, ENDOMETRIOSIS, PELVIC MASS AND PELVIC ABSCESS. CONCOMITANT PRODUCTS INCLUDED NAPROXEN, PANTOPRAZOLE AND SALBUTAMOL (ALBUTEROL). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHOE (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6)2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI") AND MIGRAINE ("MIGRAINE/HEADACHE"). IN (B)(6)2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6)2011, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL. DISCHARGE"), 3 MONTHS 14 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN/CHRONIC"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"), WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES ,OTHER") AND UNDERWENT HERNIA REPAIR ("HERNIA REPAIR"). THE PATIENT WAS TREATED WITH SURGERY (B)(6)2015- TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED); (B)(6)2017- BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, CYSTITIS, VAGINAL INFECTION, URINARY TRACT INFECTION AND MIGRAINE HAD RESOLVED, THE VAGINAL ABSCESS, DYSMENORRHOEA, ABDOMINAL PAIN, FATIGUE, HORMONE LEVEL ABNORMAL, HERNIA REPAIR AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HERNIA REPAIR, HORMONE LEVEL ABNORMAL, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL ABSCESS, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2011: TEST: BILATERAL OCCLUSION. ULTRASOUND SCAN VAGINA - ON (B)(6)2011: NEGATIVE PELVIC ULTRASOUND. BILATERAL TUBAL OCCLUSION DEVICES NOTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS : ABDOMINAL PAIN LOWER, DYSMENORRHEA, PELVIC PAIN, DYSPAREUNIA LOT NUMBER:841528, MANUFACTURE DATE:2011/03, EXPIRATION DATE:2014/03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-OCT-2019: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 PELVIC PAIN ('PELVIC PAIN/ PAIN') AND VAGINAL ABSCESS ('INFECTION (OTHER) DESCRIBE: ABSCESS ¿ VAGINAL CUFF') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRITIS, LEG PAIN, MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED DIABETES SINCE 2016, SKIN DISORDER SINCE 2016, ASTHMA SINCE 2009, INGUINAL HERNIA REPAIR, GASTRITIS, LIBIDO DECREASED, VAGINAL DRYNESS, ENDOMETRIOSIS, PELVIC MASS AND PELVIC ABSCESS. CONCOMITANT PRODUCTS INCLUDED NAPROXEN, PANTOPRAZOLE AND SALBUTAMOL (ALBUTEROL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA (""DYSMENORRHOEA" (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI") AND MIGRAINE ("MIGRAINE/HEADACHE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL. DISCHARGE"), 3 MONTHS 14 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN,CHRONIC."), VAGINAL ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"), WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES ,OTHER") AND UNDERWENT HERNIA REPAIR ("HERNIA REPAIR"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2015- TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED); (B)(6) 2017- BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, CYSTITIS, VAGINAL INFECTION, URINARY TRACT INFECTION AND MIGRAINE HAD RESOLVED, THE DYSMENORRHOEA, ABDOMINAL PAIN, FATIGUE, HORMONE LEVEL ABNORMAL, HERNIA REPAIR, VAGINAL ABSCESS AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HERNIA REPAIR, HORMONE LEVEL ABNORMAL, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL ABSCESS, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TEST: BILATERAL OCCLUSION. ULTRASOUND SCAN VAGINA - ON (B)(6) 2011: NEGATIVE PELVIC ULTRASOUND. BILATERAL TUBAL OCCLUSION DEVICES NOTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS : ABDOMINAL PAIN LOWER, DYSMENORRHEA, PELVIC PAIN, DYSPAREUNIA. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: UPDATED COMPANY CAUSALITY COMMENT. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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 ("DYSMENORRHOE (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN,CHRONIC."), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), VAGINAL DISCHARGE ("VAGINAL. DISCHARGE"), CYSTITIS ("BLADDER INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINE") AND HEADACHE ("HEADACHES"), WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES ,OTHER") AND UNDERWENT HERNIA REPAIR ("HERNIA REPAIR"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) SALPINGECTOMY. (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BLADDER DISORDER AND URINARY TRACT DISORDER HAD RESOLVED AND THE DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL DISCHARGE, CYSTITIS, VAGINAL INFECTION, URINARY TRACT INFECTION, FATIGUE, MIGRAINE, HEADACHE, HORMONE LEVEL ABNORMAL AND HERNIA REPAIR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HERNIA REPAIR, HORMONE LEVEL ABNORMAL, MIGRAINE, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TEST: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-AUG-2019: PLAINTIFF FACT SHEET RECEIVED, NEW REPORTER, CASE BECOME SIGNIFICANT ESSURE INDICATION, LAB DATA, STOP DATE AND EVENT INJURY REPLACE WITH DYSMENNORHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN /ABDOMINAL PAIN, CHRONIC, BLADDER PROBLEMS. , URINARY PROBLEMS, VAGINAL. DISCHARGE, BLADDER INFECTION, VAGINAL INFECTION, UTI, FATIGUE, MIGRAINE, HEADACHES, HORMONAL CHANGES AND OTHER HERNIA REPAIR WERE ADDED. INCIDENT NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. 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 |
|---|---|---|---|---|---|---|---|
| 728376 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841528 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | ALBUTEROL [SALBUTAMOL]| ALBUTEROL [SALBUTAMOL]| ALBUTEROL [SALBUTAMOL]| NAPROXEN| NAPROXEN| NAPROXEN| PANTOPRAZOLE| PANTOPRAZOLE| PANTOPRAZOLE |