ESSURE
Report
- Report Number
- 2951250-2017-08623
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- January 1, 2014
- Report Date
- November 28, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSIVE DISORDER, PAIN IN EXTREMITY, BONE PAIN, ACUTE SINUSITIS, HEMORRHOIDS, RESPIRATORY TRACT CONGESTION, COUGH, EAR PAIN, ACUTE BRONCHITIS, POSTNASAL DRIP, UPPER BACK PAIN, STIFFNESS, SORENESS BREAST, NAUSEA, FACIAL PAIN, LYMPHADENOPATHY, RESPIRATORY INFECTION, CERVICAL PAP SMEAR NORMAL, LEG PAIN, PAIN IN ELBOW, JOINT CREPITATION, JOINT PAIN, ACNE, ALLERGIC RHINITIS, FIBROMYALGIA, MIGRAINE, HEADACHE, RESTLESS LEGS SYNDROME, METRORRHAGIA, MENSES IRREGULAR, WRIST PAIN AND ACNE VULGARIS. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, IRREGULAR PERIODS, UTERINE BLEEDING, ACUTE POST HEMORRHAGIC ANEMIA, POSTOPERATIVE PAIN, SWELLING OF FEET AND SWOLLEN GLANDS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN (MOTRIN), LEVOFLOXACIN (LEVAQUIN) AND PARACETAMOL (TYLENOL REGULAR). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION AND DYSPAREUNIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS UNKNOWN TO THE REPORTER. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AT THE COMPLETION OF PLACEMENT, 3 COILS WERE SEEN ON THE LEFT AND 1 COIL WAS SEEN ON THE RIGHT. DISCREPANCY NOTED IN DATE OF INSERTION AND DATE OF REMOVAL: (B)(6) 2011, (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON AN UNKNOWN DATE: RECEIVED IN FORMALIN IN A CONTAINER LABELED WITH (B)(6). NUMBER, AND "UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES" IS A 116.69 GRAMS HYSTERECTOMY COMPRISED OF A UTERUS (6.0 X 7.0 X 4.5 CM), CERVIX (3.3 CM IN LENGTH X 3.3 CM IN DIAMETER), ATTACHED RIGHT FIMBRIATED FALLOPIAN TUBE (10.5 CM IN LENGTH X 0.6 CM IN DIAMETER) AND ATTACHED LEFT FIMBRIATED FALLOPIAN TUBE (8.0 CM IN LENGTH X 0.6 CM IN DIAMETER). THE SEROSAL SURFACE IS TAN-PINK, SMOOTH AND GLISTENING. THE ECTOCERVIX IS GRAY-TAN AND SMOOTH WITH A 1.0 CM SLIT-LIKE OS. THE UTERUS IS OPENED TO REVEAL TANPINK, HERRINGBONE MUCOSA LINING THE ENDOCERVICAL CANAL AND TRANSITIONING TO TAN-PINK, HEMORRHAGIC MUCOSA LINING A TRIANGULAR ENDOMETRIAL CAVITY AND MEASURING 1.0 CM IN THICKNESS. NO MASSES OR NODULES ARE SEEN WITHIN THE ENDOMETRIUM. THE SPECIMEN IS SERIALLY SECTIONED TO REVEAL TAN, SPONGY MYOMETRIUM (2.0 CM IN GREATEST THICKNESS). BOTH FALLOPIAN TUBES ARE PURPLE-PINK, SMOOTH AND GLISTENING AND SERIALLY SECTIONED TO REVEAL RED, HEMORRHAGIC CUT SURFACE WITH METALLIC WIRE OCCLUDING THE LUMEN IMMEDIATELY DISTAL TO THE CORNU AND SITE OF FALLOPIAN TUBE ATTACHMENT. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS: A 1: POSTERIOR CERVIX, A2: ANTERIOR CERVIX, A3: FULL THICKNESS POSTERIOR ENDOMYOMETRIUM, A4: ANTERIOR FULL THICKNESS ENDOMYOMETRIUM, A5: RIGHT FALLOPIAN TUBE, A6: LEFT FALLOPIAN TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN , ABDOMINAL PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORDS: PREGNANCY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-APR-2019: QUALITY SAFETY EVALUATION OF PTC. 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 PELVIC PAIN ("PELVIC PAIN/PAIN") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890) 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 "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSIVE DISORDER. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, IRREGULAR PERIODS, UTERINE BLEEDING, HEMORRHAGIC ANEMIA, POSTOPERATIVE PAIN, SWELLING OF FEET AND SWOLLEN GLANDS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN (MOTRIN) AND PARACETAMOL (TYLENOL REGULAR). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AT THE COMPLETION OF PLACEMENT, 3 COILS WERE SEEN ON THE LEFT AND 1 COIL WAS SEEN ON THE RIGHT. DISCREPANCY NOTED IN DATE OF INSERTION AND DATE OF REMOVAL:- (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON AN UNKNOWN DATE: RECEIVED IN FORMALIN IN A CONTAINER LABELED WITH KELLY NEUENKIRK, HOSPITAL NUMBER, AND "UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES" IS A 116.69 GRAMS HYSTERECTOMY COMPRISED OF A UTERUS (6.0 X 7.0 X 4.5 CM), CERVIX (3.3 CM IN LENGTH X 3.3 CM IN DIAMETER), ATTACHED RIGHT FIMBRIATED FALLOPIAN TUBE (10.5 CM IN LENGTH X 0.6 CM IN DIAMETER) AND ATTACHED LEFT FIMBRIATED FALLOPIAN TUBE (8.0 CM IN LENGTH X 0.6 CM IN DIAMETER). THE SEROSAL SURFACE IS TAN-PINK, SMOOTH AND GLISTENING. THE ECTOCERVIX IS GRAY-TAN AND SMOOTH WITH A 1.0 CM SLIT-LIKE OS. THE UTERUS IS OPENED TO REVEAL TANPINK, HERRINGBONE MUCOSA LINING THE ENDOCERVICAL CANAL AND TRANSITIONING TO TAN-PINK, HEMORRHAGIC MUCOSA LINING A TRIANGULAR ENDOMETRIAL CAVITY AND MEASURING 1.0 CM IN THICKNESS. NO MASSES OR NODULES ARE SEEN WITHIN THE ENDOMETRIUM. THE SPECIMEN IS SERIALLY SECTIONED TO REVEAL TAN, SPONGY MYOMETRIUM (2.0 CM IN GREATEST THICKNESS). BOTH FALLOPIAN TUBES ARE PURPLE-PINK, SMOOTH AND GLISTENING AND SERIALLY SECTIONED TO REVEAL RED, HEMORRHAGIC CUT SURFACE WITH METALLIC WIRE OCCLUDING THE LUMEN IMMEDIATELY DISTAL TO THE CORNU AND SITE OF FALLOPIAN TUBE ATTACHMENT. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS: POSTERIOR CERVIX. ANTERIOR CERVIX. FULL THICKNESS POSTERIOR ENDOMYOMETRIUM. ANTERIOR FULL THICKNESS ENDOMYOMETRIUM. RIGHT FALLOPIAN TUBE. LEFT FALLOPIAN TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN , ABDOMINAL PAIN . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-FEB-2019: PFS AND MR RECEIVED. REPORTERS INFORMATION UPDATED.EVENT:MEDICAL DEVICE REMOVAL WERE UPDATED TO ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), DYSMENORRHEA(CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO WERE ADDED. OUTCOME OF EVENT: PAIN WERE UPDATED. MEDICAL HISTORY, LAB DATA 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 PELVIC PAIN ("PELVIC PAIN/PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSIVE DISORDER, PAIN IN EXTREMITY, BONE PAIN, ACUTE SINUSITIS, HEMORRHOIDS, RESPIRATORY TRACT CONGESTION, COUGH, EAR PAIN, ACUTE BRONCHITIS, POSTNASAL DRIP, UPPER BACK PAIN, STIFFNESS, SORENESS BREAST, NAUSEA, FACIAL PAIN, LYMPHADENOPATHY, RESPIRATORY INFECTION, CERVICAL PAP SMEAR NORMAL, LEG PAIN, PAIN IN ELBOW, JOINT CREPITATION, JOINT PAIN, ACNE, ALLERGIC RHINITIS, FIBROMYALGIA, MIGRAINE, HEADACHE, RESTLESS LEGS SYNDROME, METRORRHAGIA, MENSES IRREGULAR, WRIST PAIN AND ACNE VULGARIS. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, IRREGULAR PERIODS, UTERINE BLEEDING, ACUTE POST HEMORRHAGIC ANEMIA, POSTOPERATIVE PAIN, SWELLING OF FEET AND SWOLLEN GLANDS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN (MOTRIN), LEVOFLOXACIN (LEVAQUIN) AND PARACETAMOL (TYLENOL REGULAR). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION AND DYSPAREUNIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS UNKNOWN TO THE REPORTER. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AT THE COMPLETION OF PLACEMENT, 3 COILS WERE SEEN ON THE LEFT AND 1 COIL WAS SEEN ON THE RIGHT. DISCREPANCY NOTED IN DATE OF INSERTION AND DATE OF REMOVAL:- 11-MAY-2011,21-APR-2016 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON AN UNKNOWN DATE: RECEIVED IN FORMALIN IN A CONTAINER LABELED WITH KELLY NEUENKIRK, HOSPITAL NUMBER, AND "UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES" IS A 116.69 GRAMS HYSTERECTOMY COMPRISED OF A UTERUS (6.0 X 7.0 X 4.5 CM), CERVIX (3.3 CM IN LENGTH X 3.3 CM IN DIAMETER), ATTACHED RIGHT FIMBRIATED FALLOPIAN TUBE (10.5 CM IN LENGTH X 0.6 CM IN DIAMETER) AND ATTACHED LEFT FIMBRIATED FALLOPIAN TUBE (8.0 CM IN LENGTH X 0.6 CM IN DIAMETER). THE SEROSAL SURFACE IS TAN-PINK, SMOOTH AND GLISTENING. THE ECTOCERVIX IS GRAY-TAN AND SMOOTH WITH A 1.0 CM SLIT-LIKE OS. THE UTERUS IS OPENED TO REVEAL TANPINK, HERRINGBONE MUCOSA LINING THE ENDOCERVICAL CANAL AND TRANSITIONING TO TAN-PINK, HEMORRHAGIC MUCOSA LINING A TRIANGULAR ENDOMETRIAL CAVITY AND MEASURING 1.0 CM IN THICKNESS. NO MASSES OR NODULES ARE SEEN WITHIN THE ENDOMETRIUM. THE SPECIMEN IS SERIALLY SECTIONED TO REVEAL TAN, SPONGY MYOMETRIUM (2.0 CM IN GREATEST THICKNESS). BOTH FALLOPIAN TUBES ARE PURPLE-PINK, SMOOTH AND GLISTENING AND SERIALLY SECTIONED TO REVEAL RED, HEMORRHAGIC CUT SURFACE WITH METALLIC WIRE OCCLUDING THE LUMEN IMMEDIATELY DISTAL TO THE CORNU AND SITE OF FALLOPIAN TUBE ATTACHMENT. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS: A 1: POSTERIOR CERVIX. A2: ANTERIOR CERVIX. A3: FULL THICKNESS POSTERIOR ENDOMYOMETRIUM. A4: ANTERIOR FULL THICKNESS ENDOMYOMETRIUM. A5: RIGHT FALLOPIAN TUBE. A6: LEFT FALLOPIAN TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN , ABDOMINAL PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORDS: PREGNANCY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-FEB-2019: MEDICAL RECORDS RECEIVED, REPORTERS ADDED, EVENT PREGNANCY CAPTURED FROM MEDICAL RECORDS. PATIENTS MEDICAL HISTORY 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 UTERINE PERFORATION ('PERFORATION (UTERUS)'), PELVIC PAIN ('PELVIC PAIN/PAIN'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)/ABNORMAL BLEEDING (GENERAL)') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890) 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 "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSIVE DISORDER, PAIN IN EXTREMITY, BONE PAIN, ACUTE SINUSITIS, HEMORRHOIDS, RESPIRATORY TRACT CONGESTION, COUGH, EAR PAIN, ACUTE BRONCHITIS, POSTNASAL DRIP, UPPER BACK PAIN, STIFFNESS, SORENESS BREAST, NAUSEA, FACIAL PAIN, LYMPHADENOPATHY, RESPIRATORY INFECTION, CERVICAL PAP SMEAR NORMAL, LEG PAIN, PAIN IN ELBOW, JOINT CREPITATION, JOINT PAIN, ACNE, ALLERGIC RHINITIS, FIBROMYALGIA, MIGRAINE, HEADACHE, RESTLESS LEGS SYNDROME, METRORRHAGIA, MENSES IRREGULAR, WRIST PAIN AND ACNE VULGARIS. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, IRREGULAR PERIODS, UTERINE BLEEDING, ACUTE POST HEMORRHAGIC ANEMIA, POSTOPERATIVE PAIN, SWELLING OF FEET, SWOLLEN GLANDS AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, IBUPROFEN (MOTRIN), LEVOFLOXACIN (LEVAQUIN), MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PARACETAMOL (TYLENOL REGULAR). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN/LOWER ABDOMINAL PAIN"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, FATIGUE, WEIGHT INCREASED AND ALOPECIA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS UNKNOWN TO THE REPORTER. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AT THE COMPLETION OF PLACEMENT, 3 COILS WERE SEEN ON THE LEFT AND 1 COIL WAS SEEN ON THE RIGHT. CURRENT WEIGHT 169LBS. DISCREPANCY NOTED IN DATE OF INSERTION AND DATE OF REMOVAL:- (B)(6) 2011,(B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28 KG/SQM. PATHOLOGY TEST - ON AN UNKNOWN DATE: RECEIVED IN FORMALIN IN A CONTAINER LABELED WITH KELLY NEUENKIRK, HOSPITAL NUMBER, AND "UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES" IS A 116.69 GRAMS HYSTERECTOMY COMPRISED OF A UTERUS (6.0 X 7.0 X 4.5 CM), CERVIX (3.3 CM IN LENGTH X 3.3 CM IN DIAMETER), ATTACHED RIGHT FIMBRIATED FALLOPIAN TUBE (10.5 CM IN LENGTH X 0.6 CM IN DIAMETER) AND ATTACHED LEFT FIMBRIATED FALLOPIAN TUBE (8.0 CM IN LENGTH X 0.6 CM IN DIAMETER). THE SEROSAL SURFACE IS TAN-PINK, SMOOTH AND GLISTENING. THE ECTOCERVIX IS GRAY-TAN AND SMOOTH WITH A 1.0 CM SLIT-LIKE OS. THE UTERUS IS OPENED TO REVEAL TANPINK, HERRINGBONE MUCOSA LINING THE ENDOCERVICAL CANAL AND TRANSITIONING TO TAN-PINK, HEMORRHAGIC MUCOSA LINING A TRIANGULAR ENDOMETRIAL CAVITY AND MEASURING 1.0 CM IN THICKNESS. NO MASSES OR NODULES ARE SEEN WITHIN THE ENDOMETRIUM. THE SPECIMEN IS SERIALLY SECTIONED TO REVEAL TAN, SPONGY MYOMETRIUM (2.0 CM IN GREATEST THICKNESS). BOTH FALLOPIAN TUBES ARE PURPLE-PINK, SMOOTH AND GLISTENING AND SERIALLY SECTIONED TO REVEAL RED, HEMORRHAGIC CUT SURFACE WITH METALLIC WIRE OCCLUDING THE LUMEN IMMEDIATELY DISTAL TO THE CORNU AND SITE OF FALLOPIAN TUBE ATTACHMENT. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS: A 1: POSTERIOR CERVIX A2: ANTERIOR CERVIX A3: FULL THICKNESS POSTERIOR ENDOMYOMETRIUM A4: ANTERIOR FULL THICKNESS ENDOMYOMETRIUM A5: RIGHT FALLOPIAN TUBE A6: LEFT FALLOPIAN TUBE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: UTERUS ANTERIOR 87X58X46 MM, ANTEVERTED. ES 10 .3MM (HYPERECHOIC AN D FLUID FILLED). OVARIES UNREMARKABLE BILATERALLY WITH PROBABLE CLC ON RIGHT. MINIMAL FREE FLUID IN CUL-DE-SAC. ESSURE COILS NOTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN , ABDOMINAL PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORDS: PREGNANCY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-NOV-2019: PFS RECEIVED. OUTCOME OF THE GENITAL BLEEDING, ABDOMINAL PAIN LOWER AND DYSMENORRHEA WERE UPDATED. 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 UTERINE PERFORATION ("PERFORATION (UTERUS)"), PELVIC PAIN ("PELVIC PAIN/PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890) 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 "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSIVE DISORDER, PAIN IN EXTREMITY, BONE PAIN, ACUTE SINUSITIS, HEMORRHOIDS, RESPIRATORY TRACT CONGESTION, COUGH, EAR PAIN, ACUTE BRONCHITIS, POSTNASAL DRIP, UPPER BACK PAIN, STIFFNESS, SORENESS BREAST, NAUSEA, FACIAL PAIN, LYMPHADENOPATHY, RESPIRATORY INFECTION, CERVICAL PAP SMEAR NORMAL, LEG PAIN, PAIN IN ELBOW, JOINT CREPITATION, JOINT PAIN, ACNE, ALLERGIC RHINITIS, FIBROMYALGIA, MIGRAINE, HEADACHE, RESTLESS LEGS SYNDROME, METRORRHAGIA, MENSES IRREGULAR, WRIST PAIN AND ACNE VULGARIS. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, IRREGULAR PERIODS, UTERINE BLEEDING, ACUTE POST HEMORRHAGIC ANEMIA, POSTOPERATIVE PAIN, SWELLING OF FEET, SWOLLEN GLANDS AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN (MOTRIN), LEVOFLOXACIN (LEVAQUIN) AND PARACETAMOL (TYLENOL REGULAR). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, FATIGUE, WEIGHT INCREASED, ALOPECIA AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS UNKNOWN TO THE REPORTER. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AT THE COMPLETION OF PLACEMENT, 3 COILS WERE SEEN ON THE LEFT AND 1 COIL WAS SEEN ON THE RIGHT. CURRENT WEIGHT 169LBS. DISCREPANCY NOTED IN DATE OF INSERTION AND DATE OF REMOVAL:- (B)(6) 2011,(B)(6) 2016 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28 KG/SQM. PATHOLOGY TEST - ON AN UNKNOWN DATE: RECEIVED IN FORMALIN IN A CONTAINER LABELED WITH (B)(6) HOSPITAL NUMBER, AND "UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES" IS A 116.69 GRAMS HYSTERECTOMY COMPRISED OF A UTERUS (6.0 X 7.0 X 4.5 CM), CERVIX (3.3 CM IN LENGTH X 3.3 CM IN DIAMETER), ATTACHED RIGHT FIMBRIATED FALLOPIAN TUBE (10.5 CM IN LENGTH X 0.6 CM IN DIAMETER) AND ATTACHED LEFT FIMBRIATED FALLOPIAN TUBE (8.0 CM IN LENGTH X 0.6 CM IN DIAMETER). THE SEROSAL SURFACE IS TAN-PINK, SMOOTH AND GLISTENING. THE ECTOCERVIX IS GRAY-TAN AND SMOOTH WITH A 1.0 CM SLIT-LIKE OS. THE UTERUS IS OPENED TO REVEAL TANPINK, HERRINGBONE MUCOSA LINING THE ENDOCERVICAL CANAL AND TRANSITIONING TO TAN-PINK, HEMORRHAGIC MUCOSA LINING A TRIANGULAR ENDOMETRIAL CAVITY AND MEASURING 1.0 CM IN THICKNESS. NO MASSES OR NODULES ARE SEEN WITHIN THE ENDOMETRIUM. THE SPECIMEN IS SERIALLY SECTIONED TO REVEAL TAN, SPONGY MYOMETRIUM (2.0 CM IN GREATEST THICKNESS). BOTH FALLOPIAN TUBES ARE PURPLE-PINK, SMOOTH AND GLISTENING AND SERIALLY SECTIONED TO REVEAL RED, HEMORRHAGIC CUT SURFACE WITH METALLIC WIRE OCCLUDING THE LUMEN IMMEDIATELY DISTAL TO THE CORNU AND SITE OF FALLOPIAN TUBE ATTACHMENT. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS: A 1: POSTERIOR CERVIX A2: ANTERIOR CERVIX A3: FULL THICKNESS POSTERIOR ENDOMYOMETRIUM A4: ANTERIOR FULL THICKNESS ENDOMYOMETRIUM A5: RIGHT FALLOPIAN TUBE A6: LEFT FALLOPIAN TUBE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: UTERUS ANTERIOR 87X58X46 MM, ANTEVERTED. ES 10 .3MM (HYPERECHOIC AN D FLUID FILLED). OVARIES UNREMARKABLE BILATERALLY WITH PROBABLE CLC ON RIGHT. MINIMAL FREE FLUID IN CUL-DE-SAC. ESSURE COILS NOTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN , ABDOMINAL PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA MEDICAL RECORDS: PREGNANCY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS AND MEDICAL RECORD RECEIVED. EVENTS ADDED: ABNORMAL BLEEDING (GENERAL) , BLADDER OR URINARY PROBLEMS OR CHANGES , MIGRAINES, HEADACHES , FATIGUE , PERFORATION (UTERUS), WEIGHT GAIN, HAIR LOSS, LOWER ABDOMINAL PAIN. REPORTER'S INFORMATION, MEDICAL HISTORY AND LAB DATA WAS 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 MEDICAL DEVICE REMOVAL ("UNDERWENT SURGERY TO REMOVE THE DEFECTIVE DEVICE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 4 YEARS 11 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE DEFECTIVE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 834420 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | DEPO-PROVERA| IBUPROFEN| LEVAQUIN| LEVAQUIN| LEVAQUIN| LEVAQUIN| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| TYLENOL REGULAR| TYLENOL REGULAR| TYLENOL REGULAR| TYLENOL REGULAR| TYLENOL REGULAR |