ESSURE
Report
- Report Number
- 2951250-2020-14635
- Event Type
- Injury
- Date Received
- September 23, 2020
- Report Date
- April 29, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('MY UTERUS CAUSING A EXCRUCIATING SHARP PAIN ON THE LEFT'), GENERAL PHYSICAL HEALTH DETERIORATION ('MY HEALTH HAS SUBSTANTIALLY DECLINED') AND DIABETES MELLITUS INADEQUATE CONTROL ('DIABETES UNABLE TO BE CONTROLLED DESPITE DIETARY CHANGES AND MEDICATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810881) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED AMITRIPTYLINE, CEFIXIME (FLEXERIL), DIPHENHYDRAMINE HYDROCHLORIDE, FISH OIL, GLIPIZIDE, IBUPROFEN, IRON, ONDANSETRON (ZOFRAN), PARACETAMOL (ACETAMINOPHEN) AND VITAMIN D NOS (VITAMIN D). 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), GENERAL PHYSICAL HEALTH DETERIORATION (SERIOUSNESS CRITERION DISABILITY), DIABETES MELLITUS INADEQUATE CONTROL (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE EXPULSION ("NEVER IMPLANTED PROPERLY/MY LEFT COIL IS MORE DISTAL AND INTO MY UTERUS"), MENORRHAGIA ("MENSTRUAL BLEEDING"), ANAEMIA ("ANEMIA"), METRORRHAGIA ("SPOTTING IN BETWEEN PERIODS"), DYSPAREUNIA ("PAINFUL SEX"), CYST ("CYSTS"), MIGRAINE ("MIGRAINE"), BACK PAIN ("LOW BACK PAIN"), ARTHRALGIA ("HIP PAIN"), PAIN IN EXTREMITY ("LEG PAIN"), TOOTH DISORDER ("DENTAL PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG"), MOOD SWINGS ("MOOD SWINGS") AND DEPRESSION ("DEPRESSION") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED.). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, DIABETES MELLITUS INADEQUATE CONTROL, DEVICE EXPULSION, MENORRHAGIA, ANAEMIA, METRORRHAGIA, DYSPAREUNIA, UTERINE LEIOMYOMA, CYST, MIGRAINE, BACK PAIN, ARTHRALGIA, PAIN IN EXTREMITY, TOOTH DISORDER, FEELING ABNORMAL, MOOD SWINGS AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANAEMIA, ARTHRALGIA, BACK PAIN, CYST, DEPRESSION, DEVICE EXPULSION, DIABETES MELLITUS INADEQUATE CONTROL, DYSPAREUNIA, FEELING ABNORMAL, GENERAL PHYSICAL HEALTH DETERIORATION, MENORRHAGIA, METRORRHAGIA, MIGRAINE, MOOD SWINGS, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER AND UTERINE LEIOMYOMA WITH ESSURE. THE REPORTER COMMENTED: SERIOUS INJURY CRITERION: DISABILITY/PERMANENT DAMAGE, REQUIRED INTERVENTION AND EVENT DATE (B)(6) 2011 WERE REPORTED, BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. LOT NUMBER: 810881 MANUFACTURE DATE: 2010-12 EXPIRATION DATE: 2013-12 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-SEP-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.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5081723) ON 14-DEC-2018. THE MOST RECENT INFORMATION WAS RECEIVED ON 05-MAR-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('MY UTERUS CAUSING A EXRUCIATING SHARP PAIN ON THE LEFT'), GENERAL PHYSICAL HEALTH DETERIORATION ('MY HEALTH HAS SUBSTANTIALLY DECLINED') AND DIABETES MELLITUS INADEQUATE CONTROL ('DIABETES UNABLE TO BE CONTROLLED DESPITE DIETARY CHANGES AND MEDICATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810881) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED AMITRIPTYLINE, ASCORBIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN D NOS (ZIBAVIT MULTIVITAMIN), CALCIUM CARBONATE;COLECALCIFEROL (CALCIUM D3), CEFIXIME (FLEXERIL), CYANOCOBALAMIN (B12), DIPHENHYDRAMINE HYDROCHLORIDE, FAMOTIDINE;IBUPROFEN (DUEXIS), FERROUS SULFATE (FERROUS SULPHATE), FISH OIL, GLIPIZIDE, HYDROCODONE, IBUPROFEN, IRON, METOPROLOL, ONDANSETRON (ZOFRAN), PARACETAMOL (ACETAMINOPHEN), PREGABALIN (LYRICA), SEMAGLUTIDE (OZEMPIC), SENNA SPP. (SENNA) AND VITAMIN D NOS (VITAMIN D). 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), GENERAL PHYSICAL HEALTH DETERIORATION (SERIOUSNESS CRITERION DISABILITY), DIABETES MELLITUS INADEQUATE CONTROL (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE EXPULSION ("NEVER IMPLANTED PROPERLY/MY LEFT COIL IS MORE DISTAL AND INTO MY UTERUS"), MENORRHAGIA ("MENSTRUAL BLEEDING"), ANAEMIA ("ANEMIA"), METRORRHAGIA ("SPOTTING IN BETWEEN PERIODS"), DYSPAREUNIA ("PAINFUL SEX"), CYST ("CYSTS"), MIGRAINE ("MIGRAINE"), BACK PAIN ("LOW BACK PAIN"), ARTHRALGIA ("HIP PAIN"), PAIN IN EXTREMITY ("LEG PAIN"), TOOTH DISORDER ("DENTAL PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG"), MOOD SWINGS ("MOOD SWINGS"), DEPRESSION ("DEPRESSION"), TACHYCARDIA ("TACHYCARDIA") AND PALPITATIONS ("FIRST NOTICED HEART PALPITATIONS WITH ESSURE BIRTH CONTROL") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS") AND HEART RATE INCREASED ("HEART RATE HAS BEEN NOTICEABLE HIGH 101-130 FOR SEVERAL MONTHS OR MORE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED.). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, DIABETES MELLITUS INADEQUATE CONTROL, DEVICE EXPULSION, MENORRHAGIA, ANAEMIA, METRORRHAGIA, DYSPAREUNIA, UTERINE LEIOMYOMA, CYST, MIGRAINE, BACK PAIN, ARTHRALGIA, PAIN IN EXTREMITY, TOOTH DISORDER, FEELING ABNORMAL, MOOD SWINGS, DEPRESSION AND HEART RATE INCREASED OUTCOME WAS UNKNOWN AND THE TACHYCARDIA AND PALPITATIONS HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANAEMIA, ARTHRALGIA, BACK PAIN, CYST, DEPRESSION, DEVICE EXPULSION, DIABETES MELLITUS INADEQUATE CONTROL, DYSPAREUNIA, FEELING ABNORMAL, GENERAL PHYSICAL HEALTH DETERIORATION, MENORRHAGIA, METRORRHAGIA, MIGRAINE, MOOD SWINGS, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER AND UTERINE LEIOMYOMA WITH ESSURE. THE REPORTER CONSIDERED HEART RATE INCREASED, PALPITATIONS AND TACHYCARDIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SERIOUS INJURY CRITERION: DISABILITY/PERMANENT DAMAGE, REQUIRED INTERVENTION AND EVENT DATE (B)(6) 2011 WERE REPORTED, BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. DISCREPANCY NOTED: THE IMPLANT DATE AS PER REPORT IS (B)(6) 2011. LOT NUMBER: 810881 MANUFACTURE DATE: 2010-12 EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAR-2021: CONCOMITANT DRUGS ADDED. EVENT : " TACHYCARDIA ," FIRST NOTICED HEART PALPITATIONS WITH ESSURE BIRTH CONTROL", " HEART RATE HAS BEEN NOTICEABLE HIGH 101-130 FOR SEVERAL MONTHS OR MORE" ADDED. RCC WAS UPDATED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('MY UTERUS CAUSING A EXCRUCIATING SHARP PAIN ON THE LEFT'), GENERAL PHYSICAL HEALTH DETERIORATION ('MY HEALTH HAS SUBSTANTIALLY DECLINED') AND DIABETES MELLITUS INADEQUATE CONTROL ('DIABETES UNABLE TO BE CONTROLLED DESPITE DIETARY CHANGES AND MEDICATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810881) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED AMITRIPTYLINE, ASCORBIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN D NOS (ZIBAVIT MULTIVITAMIN), CALCIUM CARBONATE;COLECALCIFEROL (CALCIUM D3), CEFIXIME (FLEXERIL), CYANOCOBALAMIN (B12), DIPHENHYDRAMINE HYDROCHLORIDE, FAMOTIDINE;IBUPROFEN (DUEXIS), FERROUS SULFATE (FERROUS SULPHATE), FISH OIL, GLIPIZIDE, HYDROCODONE, IBUPROFEN, IRON, METOPROLOL, ONDANSETRON (ZOFRAN), PARACETAMOL (ACETAMINOPHEN), PREGABALIN (LYRICA), SEMAGLUTIDE (OZEMPIC), SENNA SPP. (SENNA) AND VITAMIN D NOS (VITAMIN D). 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), GENERAL PHYSICAL HEALTH DETERIORATION (SERIOUSNESS CRITERION DISABILITY), DIABETES MELLITUS INADEQUATE CONTROL (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE EXPULSION ("NEVER IMPLANTED PROPERLY/MY LEFT COIL IS MORE DISTAL AND INTO MY UTERUS"), MENORRHAGIA ("MENSTRUAL BLEEDING"), ANAEMIA ("ANEMIA"), METRORRHAGIA ("SPOTTING IN BETWEEN PERIODS"), DYSPAREUNIA ("PAINFUL SEX"), CYST ("CYSTS"), MIGRAINE ("MIGRAINE"), BACK PAIN ("LOW BACK PAIN"), ARTHRALGIA ("HIP PAIN"), PAIN IN EXTREMITY ("LEG PAIN"), TOOTH DISORDER ("DENTAL PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG"), MOOD SWINGS ("MOOD SWINGS"), DEPRESSION ("DEPRESSION"), TACHYCARDIA ("TACHYCARDIA") AND PALPITATIONS ("FIRST NOTICED HEART PALPITATIONS WITH ESSURE BIRTH CONTROL") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS") AND HEART RATE INCREASED ("HEART RATE HAS BEEN NOTICEABLE HIGH 101-130 FOR SEVERAL MONTHS OR MORE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED.). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, DIABETES MELLITUS INADEQUATE CONTROL, DEVICE EXPULSION, MENORRHAGIA, ANAEMIA, METRORRHAGIA, DYSPAREUNIA, UTERINE LEIOMYOMA, CYST, MIGRAINE, BACK PAIN, ARTHRALGIA, PAIN IN EXTREMITY, TOOTH DISORDER, FEELING ABNORMAL, MOOD SWINGS, DEPRESSION AND HEART RATE INCREASED OUTCOME WAS UNKNOWN AND THE TACHYCARDIA AND PALPITATIONS HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANAEMIA, ARTHRALGIA, BACK PAIN, CYST, DEPRESSION, DEVICE EXPULSION, DIABETES MELLITUS INADEQUATE CONTROL, DYSPAREUNIA, FEELING ABNORMAL, GENERAL PHYSICAL HEALTH DETERIORATION, MENORRHAGIA, METRORRHAGIA, MIGRAINE, MOOD SWINGS, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER AND UTERINE LEIOMYOMA WITH ESSURE. THE REPORTER CONSIDERED HEART RATE INCREASED, PALPITATIONS AND TACHYCARDIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SERIOUS INJURY CRITERION: DISABILITY/PERMANENT DAMAGE, REQUIRED INTERVENTION AND EVENT DATE (B)(6) 2011 WERE REPORTED, BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. DISCREPANCY NOTED: THE IMPLANT DATE AS PER REPORT IS (B)(6) 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: OCCLUSION OF THE FALLOPIAN TUBES CONFIRMED. LOT NUMBER: 810881, MANUFACTURE DATE: 2010-12, EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-APR-2021: MR RECEIVED: REPORTER INFORMATION AND LAB DATA WERE ADDED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5081723) ON 14-DEC-2018. THE MOST RECENT INFORMATION WAS RECEIVED ON 11-SEP-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('MY UTERUS CAUSING A EXCRUCIATING SHARP PAIN ON THE LEFT'), GENERAL PHYSICAL HEALTH DETERIORATION ('MY HEALTH HAS SUBSTANTIALLY DECLINED') AND DIABETES MELLITUS INADEQUATE CONTROL ('DIABETES UNABLE TO BE CONTROLLED DESPITE DIETARY CHANGES AND MEDICATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810881) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED AMITRIPTYLINE, CEFIXIME (FLEXERIL), DIPHENHYDRAMINE HYDROCHLORIDE, FISH OIL, GLIPIZIDE, IBUPROFEN, IRON, ONDANSETRON (ZOFRAN), PARACETAMOL (ACETAMINOPHEN) AND VITAMIN D NOS (VITAMIN D). 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), GENERAL PHYSICAL HEALTH DETERIORATION (SERIOUSNESS CRITERION DISABILITY), DIABETES MELLITUS INADEQUATE CONTROL (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE EXPULSION ("NEVER IMPLANTED PROPERLY/MY LEFT COIL IS MORE DISTAL AND INTO MY UTERUS"), MENORRHAGIA ("MENSTRUAL BLEEDING"), ANAEMIA ("ANEMIA"), METRORRHAGIA ("SPOTTING IN BETWEEN PERIODS"), DYSPAREUNIA ("PAINFUL SEX"), CYST ("CYSTS"), MIGRAINE ("MIGRAINE"), BACK PAIN ("LOW BACK PAIN"), ARTHRALGIA ("HIP PAIN"), PAIN IN EXTREMITY ("LEG PAIN"), TOOTH DISORDER ("DENTAL PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG"), MOOD SWINGS ("MOOD SWINGS") AND DEPRESSION ("DEPRESSION") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED.). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, DIABETES MELLITUS INADEQUATE CONTROL, DEVICE EXPULSION, MENORRHAGIA, ANAEMIA, METRORRHAGIA, DYSPAREUNIA, UTERINE LEIOMYOMA, CYST, MIGRAINE, BACK PAIN, ARTHRALGIA, PAIN IN EXTREMITY, TOOTH DISORDER, FEELING ABNORMAL, MOOD SWINGS AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANAEMIA, ARTHRALGIA, BACK PAIN, CYST, DEPRESSION, DEVICE EXPULSION, DIABETES MELLITUS INADEQUATE CONTROL, DYSPAREUNIA, FEELING ABNORMAL, GENERAL PHYSICAL HEALTH DETERIORATION, MENORRHAGIA, METRORRHAGIA, MIGRAINE, MOOD SWINGS, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER AND UTERINE LEIOMYOMA WITH ESSURE. THE REPORTER COMMENTED: SERIOUS INJURY CRITERION: DISABILITY/PERMANENT DAMAGE, REQUIRED INTERVENTION AND EVENT DATE (B)(6) 2011 WERE REPORTED, BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2020: PIF RECEIVED. CASE UPGRADED TO INCIDENT . DOB ADDED. 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 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 |
|---|---|---|---|---|---|---|---|
| 1039573 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810881 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| AMITRIPTYLINE| AMITRIPTYLINE| AMITRIPTYLINE| AMITRIPTYLINE| B12 [CYANOCOBALAMIN]| B12 [CYANOCOBALAMIN]| CALCIUM D3| CALCIUM D3| DIPHENHYDRAMINE HYDROCHLORIDE| DIPHENHYDRAMINE HYDROCHLORIDE| DIPHENHYDRAMINE HYDROCHLORIDE| DIPHENHYDRAMINE HYDROCHLORIDE| DUEXIS| DUEXIS| FERROUS SULPHATE [FERROUS SULFATE]| FERROUS SULPHATE [FERROUS SULFATE]| FISH OIL| FISH OIL| FISH OIL| FISH OIL| FLEXERIL [CEFIXIME]| FLEXERIL [CEFIXIME]| FLEXERIL [CEFIXIME]| FLEXERIL [CEFIXIME]| GLIPIZIDE| GLIPIZIDE| GLIPIZIDE| GLIPIZIDE| HYDROCODONE| HYDROCODONE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IRON| IRON| IRON| IRON| LYRICA| LYRICA| METOPROLOL| METOPROLOL| OZEMPIC| OZEMPIC| SENNA [SENNA SPP.]| SENNA [SENNA SPP.]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| ZIBAVIT MULTIVITAMIN| ZIBAVIT MULTIVITAMIN| ZOFRAN [ONDANSETRON]| ZOFRAN [ONDANSETRON]| ZOFRAN [ONDANSETRON]| ZOFRAN [ONDANSETRON] |