FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 10053544 · Received May 13, 2020

Report

Report Number
2951250-2020-07307
Event Type
Injury
Date Received
May 13, 2020
Date of Event
October 28, 2011
Report Date
November 3, 2020
Manufacturer
BAYER PHARMA AG
Product Code
HHS
UDI-DI
10888853003051
PMA / PMN Number
P020014
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 0

THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/ PAIN') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882185) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 (B)(6) 2004, (B)(6) 2008 AND (B)(6) 2010.) AND MULTIPLE CAESAREAN SECTIONS. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, ASTHMA, BRONCHITIS, DIFFICULTY BREATHING, NECK PAIN AND ANXIETY DISORDER. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) (B)(6) 2013 TO (B)(6) 2013 FOR ANXIETY DISORDER, SALBUTAMOL SINCE 1991 FOR ASTHMA, ANTIBIOTICS FROM (B)(6) 2013 TO (B)(6) 2013 FOR BRONCHITIS AS WELL AS AMOXICILLIN;CLAVULANIC ACID (AUGMENTIN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE, ABNORMAL MENSTRUATION PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), TOOTH DISORDER ("DENTAL PROBLEMS"), HYPOAESTHESIA ("NUMBNESS IN FINGERS"), ABDOMINAL DISTENSION ("BLOATING"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL PROBLEM") AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL PROBLEMS") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS") AND WEIGHT INCREASED ("WEIGHT GAIN"), 4 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS ("SUSPICION OF MISCARRIAGE") WITH HAEMORRHAGE IN PREGNANCY. ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT") AND EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING"), MENSTRUAL DISORDER ("ABNORMAL MENSES"), ABDOMINAL PAIN LOWER ("SEVERE, ABNORMAL LOWER ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN/LOWER BACK PAIN"), HEADACHE ("HEADACHES"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSGEUSIA ("METALLIC TASTE IN HER MOUTH") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH FERROUS SULFATE (IRON), IBUPROFEN, PARACETAMOL (TYLENOL), SALBUTAMOL (ALBUTEROL) AND SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENSTRUAL DISORDER, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA, FATIGUE, HEADACHE, WEIGHT FLUCTUATION, DYSGEUSIA, ANXIETY, VAGINAL HAEMORRHAGE, MENORRHAGIA, TOOTH DISORDER, HYPOAESTHESIA, WEIGHT DECREASED AND ABDOMINAL DISTENSION HAD NOT RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, WEIGHT INCREASED, GASTROINTESTINAL DISORDER AND NERVOUS SYSTEM DISORDER OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, ANXIETY, BACK PAIN, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HYPOAESTHESIA, MENORRHAGIA, MENSTRUAL DISORDER, NERVOUS SYSTEM DISORDER, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE AT LEAST 3 COILS OUTSIDE THE OS. THIS WAS REPEATED ON THE OPPOSITE SIDE AND BOTH HAD THE SAME, ABOUT 3 COILS OUTSIDE OF THE OS. THE PATIENT TOLERATED THE PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. DOCTOR COULDN'T SEE RIGHT SIDE BECAUSE IT WAS TOO MUCH SCAR TISSUE. LEFT COIL WAS SEEN CLEARLY. PREGNANCY TEST - ON (B)(6) 2015: RESULTS: POSITIVE; ON (B)(6) 2015: RESULTS: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENTS PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-NOV-2020: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). 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.

Additional Manufacturer Narrative · 0

THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/ PAIN') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882185) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 (B)(6) 2004, (B)(6) 2008 AND (B)(6) 2010.) AND MULTIPLE CAESAREAN SECTIONS. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, ASTHMA, BRONCHITIS, DIFFICULTY BREATHING, NECK PAIN AND ANXIETY DISORDER. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) (B)(6) 2013 TO (B)(6) 2013 FOR ANXIETY DISORDER, SALBUTAMOL SINCE 1991 FOR ASTHMA, ANTIBIOTICS FROM (B)(6) 2013 TO (B)(6) 2013 FOR BRONCHITIS AS WELL AS AMOXICILLIN;CLAVULANIC ACID (AUGMENTIN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE, ABNORMAL MENSTRUATION PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), TOOTH DISORDER ("DENTAL PROBLEMS"), HYPOAESTHESIA ("NUMBNESS IN FINGERS"), ABDOMINAL DISTENSION ("BLOATING"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL PROBLEM") AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL PROBLEMS") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS") AND WEIGHT INCREASED ("WEIGHT GAIN"), 4 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS ("SUSPICION OF MISCARRIAGE") WITH HAEMORRHAGE IN PREGNANCY. ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT") AND EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING"), MENSTRUAL DISORDER ("ABNORMAL MENSES"), ABDOMINAL PAIN LOWER ("SEVERE, ABNORMAL LOWER ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN/LOWER BACK PAIN"), HEADACHE ("HEADACHES"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSGEUSIA ("METALLIC TASTE IN HER MOUTH") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH FERROUS SULFATE (IRON), IBUPROFEN, PARACETAMOL (TYLENOL), SALBUTAMOL (ALBUTEROL) AND SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENSTRUAL DISORDER, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA, FATIGUE, HEADACHE, WEIGHT FLUCTUATION, DYSGEUSIA, ANXIETY, VAGINAL HAEMORRHAGE, MENORRHAGIA, TOOTH DISORDER, HYPOAESTHESIA, WEIGHT DECREASED AND ABDOMINAL DISTENSION HAD NOT RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, WEIGHT INCREASED, GASTROINTESTINAL DISORDER AND NERVOUS SYSTEM DISORDER OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, ANXIETY, BACK PAIN, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HYPOAESTHESIA, MENORRHAGIA, MENSTRUAL DISORDER, NERVOUS SYSTEM DISORDER, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE AT LEAST 3 COILS OUTSIDE THE OS. THIS WAS REPEATED ON THE OPPOSITE SIDE AND BOTH HAD THE SAME, ABOUT 3 COILS OUTSIDE OF THE OS. THE PATIENT TOLERATED THE PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. DOCTOR COULDN'T SEE RIGHT SIDE BECAUSE IT WAS TOO MUCH SCAR TISSUE. LEFT COIL WAS SEEN CLEARLY. PREGNANCY TEST - ON (B)(6) 2015: RESULTS: POSITIVE; ON (B)(6) 2015: RESULTS: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENTS PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-APR-2020: PFS RECEIVED: ESSURE REMOVAL DONE. 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.

Description of Event or Problem · 1

THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/ PAIN') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882185) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6) 2004, (B)(6) 2008 AND (B)(6) 2010.) AND MULTIPLE CAESAREAN SECTIONS. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, ASTHMA, BRONCHITIS, DIFFICULTY BREATHING, NECK PAIN AND ANXIETY DISORDER. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) (B)(6) 2013 TO (B)(6) 2013 FOR ANXIETY DISORDER, SALBUTAMOL SINCE 1991 FOR ASTHMA, ANTIBIOTICS FROM (B)(6) 2013 TO (B)(6) 2013 FOR BRONCHITIS AS WELL AS AMOXICILLIN;CLAVULANIC ACID (AUGMENTIN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE, ABNORMAL MENSTRUATION PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), TOOTH DISORDER ("DENTAL PROBLEMS"), HYPOAESTHESIA ("NUMBNESS IN FINGERS"), ABDOMINAL DISTENSION ("BLOATING"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL PROBLEM") AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL PROBLEMS") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS") AND WEIGHT INCREASED ("WEIGHT GAIN"), 4 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS ("SUSPICION OF MISCARRIAGE") WITH HAEMORRHAGE IN PREGNANCY. ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT") AND EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING"), MENSTRUAL DISORDER ("ABNORMAL MENSES"), ABDOMINAL PAIN LOWER ("SEVERE, ABNORMAL LOWER ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN/LOWER BACK PAIN"), HEADACHE ("HEADACHES"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), DYSGEUSIA ("METALLIC TASTE IN HER MOUTH") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH FERROUS SULFATE (IRON), IBUPROFEN, PARACETAMOL (TYLENOL), SALBUTAMOL (ALBUTEROL) AND SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENSTRUAL DISORDER, ABDOMINAL PAIN LOWER, BACK PAIN, DYSPAREUNIA, FATIGUE, HEADACHE, WEIGHT FLUCTUATION, DYSGEUSIA, ANXIETY, VAGINAL HAEMORRHAGE, MENORRHAGIA, TOOTH DISORDER, HYPOAESTHESIA, WEIGHT DECREASED AND ABDOMINAL DISTENSION HAD NOT RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, WEIGHT INCREASED, GASTROINTESTINAL DISORDER AND NERVOUS SYSTEM DISORDER OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, ANXIETY, BACK PAIN, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HYPOAESTHESIA, MENORRHAGIA, MENSTRUAL DISORDER, NERVOUS SYSTEM DISORDER, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE WERE AT LEAST 3 COILS OUTSIDE THE OS. THIS WAS REPEATED ON THE OPPOSITE SIDE AND BOTH HAD THE SAME, ABOUT 3 COILS OUTSIDE OF THE OS. THE PATIENT TOLERATED THE PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.8 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. DOCTOR COULDN'T SEE RIGHT SIDE BECAUSE IT WAS TOO MUCH SCAR TISSUE. LEFT COIL WAS SEEN CLEARLY. PREGNANCY TEST ON (B)(6) 2015: RESULTS: POSITIVE; ON (B)(6) 2015: RESULTS: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENTS PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-APR-2020: PFS RECEIVED: ESSURE REMOVAL DONE. 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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
515988 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882185 10888853003051

Patients

Seq Age Sex Outcome Treatment
1 26 YR Other| R ANTIBIOTICS| ANTIBIOTICS| ANTIBIOTICS| AUGMENTIN [AMOXICILLIN,CLAVULANIC ACID]| AUGMENTIN [AMOXICILLIN,CLAVULANIC ACID]| AUGMENTIN [AMOXICILLIN,CLAVULANIC ACID]| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| SALBUTAMOL| SALBUTAMOL| SALBUTAMOL| XANAX| XANAX| XANAX