FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 8738686 · Received June 27, 2019

Report

Report Number
2951250-2019-03098
Event Type
Injury
Date Received
June 27, 2019
Date of Event
October 1, 2012
Report Date
June 12, 2020
Manufacturer
BAYER PHARMA AG
Product Code
HHS
UDI-DI
10888853003051
PMA / PMN Number
P020014
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CO, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 0

THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RASH, PAP SMEAR ABNORMAL AND LOW BACK PAIN. CONCURRENT CONDITIONS INCLUDED PELVIC PAIN FEMALE, BLOATING, NUMBNESS OF UPPER EXTREMITIES, SKIN DISORDER, JOINT PAIN, MUSCLE PAIN, DIFFICULTY SLEEPING, UTERINE NEOPLASM, CYST RUPTURE, INTRAMURAL LEIOMYOMA OF UTERUS, CERVICITIS, NABOTHIAN CYST, PARATUBAL CYST, ENDOMETRIOSIS, MENOMETRORRHAGIA, PROLAPSE AND VAGINAL CYST EXCISION. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN) (B)(6) 2012 TO (B)(6) 2012 FOR CONTRACEPTION AS WELL AS ANALGESICS, DIAZEPAM (VALIUM), IBUPROFEN, NSAIDS SINCE (B)(6) 2012, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("ALLERGIC REACTION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HYPERSENSITIVITY AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MIGRAINE, HEADACHE, NAUSEA, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: IN PREVIOUS VERSION HSG RESULTS ARE PROVIDED BUT IN CURRENT PFS PLAINTIFF CLAIMED THAT SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST. DISCREPANCY NOTED: DATE OF REMOVAL PREVIOUSLY REPORTED AS (B)(6) 2018 NOW IT IS REPORTED (B)(6) 2018. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.6 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: HEAVY VAGINAL BLEEDING, PELVIC PAIN, MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED : NEW EVENTS 'ALLERGIC REACTION' AND "GENITAL BLEEDING" WAS ADDED. OUTCOME OF THE EVENT PELVIC PAIN WAS UPDATED TO RECOVERED. 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.

Additional Manufacturer Narrative · 0

THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RASH, PAP SMEAR ABNORMAL AND LOW BACK PAIN. CONCURRENT CONDITIONS INCLUDED PELVIC PAIN FEMALE, BLOATING, NUMBNESS OF UPPER EXTREMITIES, SKIN DISORDER, JOINT PAIN, MUSCLE PAIN, DIFFICULTY SLEEPING, UTERINE NEOPLASM, CYST RUPTURE, INTRAMURAL LEIOMYOMA OF UTERUS, CERVICITIS, NABOTHIAN CYST, PARATUBAL CYST, ENDOMETRIOSIS, MENOMETRORRHAGIA, PROLAPSE AND VAGINAL CYST EXCISION. CONCOMITANT PRODUCTS INCLUDED ANALGESICS, DIAZEPAM (VALIUM), ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), IBUPROFEN, NSAIDS SINCE (B)(6) 2012, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MIGRAINE, HEADACHE, NAUSEA, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: IN PREVIOUS VERSION HSG RESULTS ARE PROVIDED BUT IN CURRENT PFS PLAINTIFF CLAIMED THAT SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.6 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: HEAVY VAGINAL BLEEDING, PELVIC PAIN, MENORRHAGIA QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

Additional Manufacturer Narrative · 0

THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RASH, PAP SMEAR ABNORMAL AND LOW BACK PAIN. CONCURRENT CONDITIONS INCLUDED PELVIC PAIN FEMALE, BLOATING, NUMBNESS OF UPPER EXTREMITIES, SKIN DISORDER, JOINT PAIN, MUSCLE PAIN, DIFFICULTY SLEEPING, UTERINE NEOPLASM, CYST RUPTURE, INTRAMURAL LEIOMYOMA OF UTERUS, CERVICITIS, NABOTHIAN CYST, PARATUBAL CYST, ENDOMETRIOSIS, MENOMETRORRHAGIA, PROLAPSE AND VAGINAL CYST EXCISION. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN) (B)(6) 2012 TO (B)(6) 2012 FOR CONTRACEPTION AS WELL AS ANALGESICS, DIAZEPAM (VALIUM), IBUPROFEN, NSAIDS SINCE (B)(6) 2012, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("ALLERGIC REACTION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HYPERSENSITIVITY AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MIGRAINE, HEADACHE, NAUSEA, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: IN PREVIOUS VERSION HSG RESULTS ARE PROVIDED BUT IN CURRENT PFS PLAINTIFF CLAIMED THAT SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST. DISCREPANCY NOTED: DATE OF REMOVAL PREVIOUSLY REPORTED AS (B)(6) 2018 NOW IT IS REPORTED (B)(6) 2018 . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.6 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-JUN-2020: QUALITY SAFETY EVALUATION OF PTC. 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.

Description of Event or Problem · 1

THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RASH, PAP SMEAR ABNORMAL AND LOW BACK PAIN. CONCURRENT CONDITIONS INCLUDED PELVIC PAIN FEMALE, BLOATING, NUMBNESS OF UPPER EXTREMITIES, SKIN DISORDER, JOINT PAIN, MUSCLE PAIN, DIFFICULTY SLEEPING, UTERINE NEOPLASM, CYST RUPTURE, INTRAMURAL LEIOMYOMA OF UTERUS, CERVICITIS, NABOTHIAN CYST, PARATUBAL CYST, ENDOMETRIOSIS, MENOMETRORRHAGIA, PROLAPSE AND CYST REMOVAL. CONCOMITANT PRODUCTS INCLUDED ANALGESICS, DIAZEPAM (VALIUM), ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), IBUPROFEN, NSAIDS SINCE (B)(6) 2012, OXYCODONE HYDROCHLORIDE; PARACETAMOL (PERCOCET) AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MIGRAINE, HEADACHE, NAUSEA, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: IN PREVIOUS VERSION HSG RESULTS ARE PROVIDED BUT IN CURRENT PFS PLAINTIFF CLAIMED THAT SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: HEAVY VAGINAL BLEEDING, PELVIC PAIN, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUN-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORDS WERE RECEIVED. EVENTS PER PFS: ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, MIGRAINES, HEADACHES, NAUSEA, DEPRESSION, MENTAL ANGUISH, WEIGHT GAIN. LOT NUMBER, MEDICAL HISTORY AND CONCURRENT CONDITION AND CONCOMITANT MEDICATION WERE ADDED. EVENT PLAINTIFF BEGAN TO EXPERIENCE COMPLICATIONS REPLACED WITH PELVIC PAIN. 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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
533735 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893037 10888853003051

Patients

Seq Age Sex Outcome Treatment
1 35 YR Other| R ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ANALGESICS| ANALGESICS| ANALGESICS| ANALGESICS| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| NSAIDS| NSAIDS| NSAIDS| NSAIDS| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| VALIUM| VALIUM| VALIUM| VALIUM| ACETAMINOPHEN| ANALGESICS| IBUPROFEN| NSAIDS| ORTHO TRI-CYCLEN| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| VALIUM