ESSURE
Report
- Report Number
- 2951250-2017-06595
- Event Type
- Injury
- Date Received
- November 16, 2017
- Date of Event
- January 1, 2009
- Report Date
- September 30, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY/ PREGNANCY (WITH COMPLICATIONS)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED SEIZURES, ANXIETY, BIPOLAR DISORDER AND OBESITY. CONCOMITANT PRODUCTS INCLUDED DOCUSATE SODIUM (COLACE) SINCE (B)(6) 2015, IBUPROFEN (MOTRIN) SINCE (B)(6) 2015, IRON SINCE (B)(6) 2015, OXYCOCET (PERCOCET) SINCE (B)(6) 2015, QUETIAPINE (SEROQUEL) SINCE (B)(6) 2015 AND SERTRALINE (ZOLOFT) SINCE (B)(6) 2015. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT INCREASED ("WEIGHT GAIN/ WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: FREQUENT UTI"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION ON AND OFF"), BLADDER DISORDER ("BLADDER OR PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD"), APHASIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY AND INABILITY TO SAY CERTAIN WORDS") AND AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"). IN 2010, THE PATIENT EXPERIENCED ARTHRITIS ("ARTHRITIS/ ARTHRITIS"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), ARTHRALGIA ("JOINT PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND LYSIS OF OMENTAL ADHESIONS.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, HEADACHE, DEPRESSION, ARTHRITIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, DYSMENORRHOEA, VISION BLURRED, FATIGUE, ALOPECIA, BLADDER DISORDER, URINARY TRACT DISORDER, POST-TRAUMATIC STRESS DISORDER, APHASIA, AMNESIA AND ARTHRALGIA OUTCOME WAS UNKNOWN, THE WEIGHT INCREASED AND NAUSEA WAS RESOLVING AND THE URINARY TRACT INFECTION AND ABDOMINAL PAIN HAD RESOLVED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AMNESIA, APHASIA, ARTHRALGIA, ARTHRITIS, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. CURRENT WEIGHT 155 LBS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-OCT-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: AT THE TIME OF REPORTING, 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.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY/ PREGNANCY (WITH COMPLICATIONS)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED SEIZURES, ANXIETY, BIPOLAR DISORDER AND OBESITY. CONCOMITANT PRODUCTS INCLUDED DOCUSATE SODIUM (COLACE) SINCE (B)(6) 2015, IBUPROFEN (MOTRIN) SINCE (B)(6) 2015, IRON SINCE (B)(6) 2015, OXYCOCET (PERCOCET) SINCE (B)(6) 2015, QUETIAPINE (SEROQUEL) SINCE (B)(6) 2015 AND SERTRALINE (ZOLOFT) SINCE (B)(6) 2015. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), WEIGHT INCREASED ("WEIGHT GAIN/ WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: FREQUENT UTI"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BLADDER DISORDER ("BLADDER OR PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), APHASIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY AND INABILITY TO SAY CERTAIN WORDS") AND MEMORY IMPAIRMENT ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY"). ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), ARTHRITIS ("ARTHRITIS/ AUTOIMMUNE DISORDER TYPE OF DISORDER: ARTHRITIS"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION ON AND OFF"), POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD"), ARTHRALGIA ("JOINT PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND LYSIS OF OMENTAL ADHESIONS.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, HEADACHE, DEPRESSION, ARTHRITIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, MIGRAINE, NAUSEA, DYSMENORRHOEA, VISION BLURRED, FATIGUE, ALOPECIA, BLADDER DISORDER, URINARY TRACT DISORDER, GENITAL HAEMORRHAGE, POST-TRAUMATIC STRESS DISORDER, APHASIA, MEMORY IMPAIRMENT AND ARTHRALGIA OUTCOME WAS UNKNOWN, THE WEIGHT INCREASED WAS RESOLVING AND THE ABDOMINAL PAIN HAD RESOLVED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, APHASIA, ARTHRALGIA, ARTHRITIS, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. CURRENT WEIGHT 155 LBS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-JUL-2018: CORRECTION FOLLOWING COMPANY INTERNAL CODING REVIEW. THE EVENT "ARTHRITIS/ AUTOIMMUNE DISORDER TYPE OF DISORDER: ARTHRITIS" WAS RECODED TO MEDDRA LLT "ARTHRITIS". 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.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY/ PREGNANCY (WITH COMPLICATIONS)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED SEIZURES, ANXIETY, BIPOLAR DISORDER AND OBESITY. CONCOMITANT PRODUCTS INCLUDED DOCUSATE SODIUM (COLACE) SINCE (B)(6) 2015, IBUPROFEN (MOTRIN) SINCE (B)(6) 2015, IRON SINCE (B)(6) 2015, OXYCOCET (PERCOCET) SINCE (B)(6) 2015, QUETIAPINE (SEROQUEL) SINCE (B)(6) 2015 AND SERTRALINE (ZOLOFT) SINCE (B)(6) 2015. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), WEIGHT INCREASED ("WEIGHT GAIN/ WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: FREQUENT UTI"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BLADDER DISORDER ("BLADDER OR PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), APHASIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY AND INABILITY TO SAY CERTAIN WORDS") AND MEMORY IMPAIRMENT ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY"). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). IN OCTOBER 2010, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), ARTHRITIS ("ARTHRITIS/ ARTHRITIS"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION ON AND OFF"), POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD"), ARTHRALGIA ("JOINT PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND LYSIS OF OMENTAL ADHESIONS.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, HEADACHE, DEPRESSION, ARTHRITIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, MIGRAINE, NAUSEA, DYSMENORRHOEA, VISION BLURRED, FATIGUE, ALOPECIA, BLADDER DISORDER, URINARY TRACT DISORDER, GENITAL HAEMORRHAGE, POST-TRAUMATIC STRESS DISORDER, APHASIA, MEMORY IMPAIRMENT AND ARTHRALGIA OUTCOME WAS UNKNOWN, THE WEIGHT INCREASED WAS RESOLVING AND THE ABDOMINAL PAIN HAD RESOLVED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, APHASIA, ARTHRALGIA, ARTHRITIS, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. CURRENT WEIGHT 155 LBS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-JUL-2018: CORRECTION FOLLOWING COMPANY INTERNAL CODING REVIEW. THE EVENT "ARTHRITIS/ AUTOIMMUNE DISORDER TYPE OF DISORDER: ARTHRITIS" WAS RECODED TO MEDDRA LLT "ARTHRITIS". 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.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY/ PREGNANCY (WITH COMPLICATIONS)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED SEIZURES, ANXIETY, BIPOLAR DISORDER AND OBESITY. CONCOMITANT PRODUCTS INCLUDED DOCUSATE SODIUM (COLACE) SINCE (B)(6) 2015, IBUPROFEN (MOTRIN) SINCE (B)(6) 2015, IRON SINCE (B)(6) 2015, OXYCOCET (PERCOCET) SINCE (B)(6) 2015, QUETIAPINE (SEROQUEL) SINCE (B)(6) 2015 AND SERTRALINE (ZOLOFT) SINCE (B)(6) 2015. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT INCREASED ("WEIGHT GAIN/ WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: FREQUENT UTI"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION ON AND OFF"), BLADDER DISORDER ("BLADDER OR PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD"), APHASIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY AND INABILITY TO SAY CERTAIN WORDS") AND AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED ARTHRITIS ("ARTHRITIS/ ARTHRITIS"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), ARTHRALGIA ("JOINT PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND LYSIS OF OMENTAL ADHESIONS.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, HEADACHE, DEPRESSION, ARTHRITIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, DYSMENORRHOEA, VISION BLURRED, FATIGUE, ALOPECIA, BLADDER DISORDER, URINARY TRACT DISORDER, POST-TRAUMATIC STRESS DISORDER, APHASIA, AMNESIA AND ARTHRALGIA OUTCOME WAS UNKNOWN, THE WEIGHT INCREASED AND NAUSEA WAS RESOLVING AND THE URINARY TRACT INFECTION AND ABDOMINAL PAIN HAD RESOLVED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AMNESIA, APHASIA, ARTHRALGIA, ARTHRITIS, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREGNANCY WITH CONTRACEPTIVE DEVICE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. CURRENT WEIGHT 155 LBS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2018: PFS RECEIVED: ADDED LOT NUMBER AND EVENT ONSET DATES AND UPDATED OUTCOME OF EVENTS. INCIDENT AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('UNINTENDED PREGNANCY/ PREGNANCY (WITH COMPLICATIONS)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. 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 4 AND CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED SEIZURES, ANXIETY, BIPOLAR DISORDER AND OBESITY. CONCOMITANT PRODUCTS INCLUDED SINCE MARCH 2015, DOCUSATE SODIUM (COLACE) SINCE MARCH 2015, IRON SINCE MARCH 2015, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) SINCE MARCH 2015, QUETIAPINE FUMARATE (SEROQUEL) SINCE MARCH 2015 AND SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE MARCH 2015. ON 4-OCT-2009, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: FREQUENT UTI"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY VISION ON AND OFF"), BLADDER DISORDER ("BLADDER OR PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD"), APHASIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY AND INABILITY TO SAY CERTAIN WORDS") AND AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2010, THE PATIENT EXPERIENCED ARTHRITIS ("ARTHRITIS/ ARTHRITIS"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). IN OCTOBER 2010, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), ARTHRALGIA ("JOINT PAIN "), ABDOMINAL PAIN ("ABDOMINAL PAIN"), FUNGAL INFECTION ("YEAST INFECTION"), PRURITUS ("ITCHING") AND SKIN IRRITATION ("IRRITATION"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND LYSIS OF OMENTAL ADHESIONS.). ESSURE WAS REMOVED ON 15-MAR-2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, HEADACHE, DEPRESSION, ARTHRITIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, DYSMENORRHOEA, VISION BLURRED, FATIGUE, ALOPECIA, BLADDER DISORDER, URINARY TRACT DISORDER, POST-TRAUMATIC STRESS DISORDER, APHASIA, AMNESIA, ARTHRALGIA, FUNGAL INFECTION, PRURITUS AND SKIN IRRITATION OUTCOME WAS UNKNOWN, THE WEIGHT INCREASED AND NAUSEA WAS RESOLVING AND THE URINARY TRACT INFECTION AND ABDOMINAL PAIN HAD RESOLVED. 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 NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AMNESIA, APHASIA, ARTHRALGIA, ARTHRITIS, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, FATIGUE, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREGNANCY WITH CONTRACEPTIVE DEVICE, PRURITUS, SKIN IRRITATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.7 KG/SQM. CURRENT WEIGHT 155 LBS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: YEAST INFECTION, ITCHING AND IRRITATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: SOCIAL MEDIA RECEIVED- NEW EVENTS YEAST INFECTION, ITCHING AND IRRITATION WERE ADDED. REPORTER'S INFORMATION 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("UNINTENDED PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT INCREASED ("WEIGHT GAIN"), HEADACHE ("HEADACHES"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, WEIGHT INCREASED, HEADACHE, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, HEADACHE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 816362 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922613 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R | COLACE| COLACE| COLACE| COLACE| COLACE| IRON| IRON| IRON| IRON| IRON| MOTRIN| MOTRIN| MOTRIN| MOTRIN| OTHER THERAPEUTIC PRODUCTS| PERCOCET| PERCOCET| PERCOCET| PERCOCET| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| SEROQUEL| SEROQUEL| SEROQUEL| SEROQUEL| SEROQUEL| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT |