ESSURE
Report
- Report Number
- 2951250-2019-04974
- Event Type
- Injury
- Date Received
- August 21, 2019
- Date of Event
- October 1, 2012
- Report Date
- June 4, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN / PAIN / PELVIC AREA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANEMIA, HYPOTENSION, HIVES, VAGINAL DELIVERY, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER SYNDROME, GASTRECTOMY AND COLECTOMY. CONCURRENT CONDITIONS INCLUDED WEAKNESS, HEPATITIS, CHRONIC DIARRHEA, NAUSEA, LIGHT HEADEDNESS, MICROCYTIC ANEMIA, MIGRAINE, EDEMA, INFLAMMATION, DACRYOADENITIS, DIARRHEA, HYPOTENSION, PYURIA, SYNCOPE AND DYSMENORRHEA. CONCOMITANT PRODUCTS INCLUDED EPHEDRINE, IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). 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 ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), ABDOMINAL PAIN ("ABDOMINAL AREA"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), MIGRAINE ("MIGRAINE HEADACHES"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"), ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"), HYPERSENSITIVITY ("ALLERGY") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, URINARY TRACT INFECTION, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, HYPERSENSITIVITY AND VAGINAL DISCHARGE HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, ANAEMIA, MIGRAINE, NAUSEA, DYSPAREUNIA, FATIGUE AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANAEMIA, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANT INFORMATION: ESSURE CONFIRMATION TEST CONDUCTED REPORTED AS NO PATIENT RECEIVED TREATMENT FOR-PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), BACK PAIN, MENORRHAGIA, UTI AND VAGINAL DISCHARGE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): 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 : ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-NOV-2019: PFS RECEIVED. CONCOMITANT MEDICATION ADDED. EVENTS ; MIGRAINE HEADACHES, NAUSEA, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS WERE ADDED. ON 20-NOV-2019: NO NEW INFORMATION RECEIVED. ON 20-NOV-2019: NO NEW INFORMATION RECEIVED. 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 ('PHYSICAL PAIN / PAIN / PELVIC AREA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANEMIA, HYPOTENSION, HIVES, VAGINAL DELIVERY, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER SYNDROME, GASTRECTOMY AND COLECTOMY. CONCURRENT CONDITIONS INCLUDED WEAKNESS, HEPATITIS, CHRONIC DIARRHEA, NAUSEA, LIGHT HEADEDNESS, MICROCYTIC ANEMIA, MIGRAINE, EDEMA, INFLAMMATION, DACRYOADENITIS, DIARRHEA, HYPOTENSION, PYURIA, SYNCOPE AND DYSMENORRHEA. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). 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 ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN ("ABDOMINAL AREA"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANT INFORMATION: ESSURE CONFIRMATION TEST CONDUCTED REPORTED AS NO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): 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 : ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-AUG-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 ('PHYSICAL PAIN / PAIN / PELVIC AREA') AND COLON CANCER ('COLON CANCER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANEMIA, HYPOTENSION, HIVES, VAGINAL DELIVERY, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER SYNDROME, GASTRECTOMY AND COLECTOMY. CONCURRENT CONDITIONS INCLUDED WEAKNESS, HEPATITIS, CHRONIC DIARRHEA, NAUSEA, LIGHT HEADEDNESS, MICROCYTIC ANEMIA, MIGRAINE, EDEMA, INFLAMMATION, DACRYOADENITIS, DIARRHEA, HYPOTENSION, PYURIA, SYNCOPE AND DYSMENORRHEA. CONCOMITANT PRODUCTS INCLUDED EPHEDRINE, IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). 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 ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), ABDOMINAL PAIN ("ABDOMINAL AREA"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), MIGRAINE ("MIGRAINE HEADACHES"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"), ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"), HYPERSENSITIVITY ("ALLERGY") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE COLON CANCER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, HYPERSENSITIVITY AND VAGINAL DISCHARGE HAD RESOLVED AND THE DEPRESSION, ANXIETY, ANAEMIA, MIGRAINE, NAUSEA, DYSPAREUNIA, FATIGUE, WEIGHT DECREASED AND COLON CANCER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANAEMIA, ANXIETY, BACK PAIN, COLON CANCER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANT INFORMATION: ESSURE CONFIRMATION TEST CONDUCTED REPORTED AS NO PATIENT RECEIVED TREATMENT FOR-PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), BACK PAIN, MENORRHAGIA, UTI AND VAGINAL DISCHARGE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): 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 : ABDOMINAL PAIN. THE FOLLOWING INFORMATION WAS RECEIVED FROM SOCIAL MEDIA COLON CANCER. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: OUTCOME OF EVENT ABNORMAL BLEEDING(VAGINAL) WAS UPDATED TO RECOVERED/RESOLVED. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN / PAIN / PELVIC AREA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANEMIA, HYPOTENSION, HIVES, VAGINAL DELIVERY, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER SYNDROME, GASTRECTOMY AND COLECTOMY. CONCURRENT CONDITIONS INCLUDED WEAKNESS, HEPATITIS, CHRONIC DIARRHEA, NAUSEA, LIGHT HEADEDNESS, MICROCYTIC ANEMIA, MIGRAINE, EDEMA, INFLAMMATION, DACRYOADENITIS, DIARRHEA, HYPOTENSION, PYURIA, SYNCOPE AND DYSMENORRHEA. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). 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 ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN ("ABDOMINAL AREA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), BACK PAIN ("BACK PAIN"), ANAEMIA ("ANEMIA"), HYPERSENSITIVITY ("ALLERGY") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, URINARY TRACT INFECTION, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, HYPERSENSITIVITY AND VAGINAL DISCHARGE HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY AND ANAEMIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANAEMIA, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, HYPERSENSITIVITY, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANT INFORMATION: ESSURE CONFIRMATION TEST CONDUCTED REPORTED AS NO PATIENT RECEIVED TREATMENT FOR-PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), BACK PAIN, MENORRHAGIA, UTI AND VAGINAL DISCHARGE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): 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 : ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2019: PFS RECEIVED- NEW EVENTS DYSMENORRHEA(CRAMPING), BACK PAIN, ANEMIA, ALLERGY AND VAGINAL DISCHARGE WERE ADDED. REPORTER AND PATIENT DEMOGRAPHY 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 ('PHYSICAL PAIN / PAIN / PELVIC AREA') AND COLON CANCER ('COLON CANCER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANEMIA, HYPOTENSION, HIVES, VAGINAL DELIVERY, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER SYNDROME, GASTRECTOMY AND COLECTOMY. CONCURRENT CONDITIONS INCLUDED WEAKNESS, HEPATITIS, CHRONIC DIARRHEA, NAUSEA, LIGHT HEADEDNESS, MICROCYTIC ANEMIA, MIGRAINE, EDEMA, INFLAMMATION, DACRYOADENITIS, DIARRHEA, HYPOTENSION, PYURIA, SYNCOPE AND DYSMENORRHEA. CONCOMITANT PRODUCTS INCLUDED EPHEDRINE, IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). 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 ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), ABDOMINAL PAIN ("ABDOMINAL AREA"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), MIGRAINE ("MIGRAINE HEADACHES"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"), ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"), HYPERSENSITIVITY ("ALLERGY") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE COLON CANCER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, URINARY TRACT INFECTION, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, HYPERSENSITIVITY AND VAGINAL DISCHARGE HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, ANAEMIA, MIGRAINE, NAUSEA, DYSPAREUNIA, FATIGUE, WEIGHT DECREASED AND COLON CANCER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANAEMIA, ANXIETY, BACK PAIN, COLON CANCER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANT INFORMATION: ESSURE CONFIRMATION TEST CONDUCTED REPORTED AS NO PATIENT RECEIVED TREATMENT FOR-PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), BACK PAIN, MENORRHAGIA, UTI AND VAGINAL DISCHARGE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): 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 : ABDOMINAL PAIN. THE FOLLOWING INFORMATION WAS RECEIVED FROM SOCIAL MEDIA COLON CANCER. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA RECEIVED. EVENT ADDED- COLON CANCER. REPORTER 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN / PAIN / PELVIC AREA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ANEMIA, HYPOTENSION, HIVES, VAGINAL DELIVERY, COLON CANCER, GASTRECTOMY AND COLECTOMY. CONCURRENT CONDITIONS INCLUDED WEAKNESS, HEPATITIS, CHRONIC DIARRHEA, NAUSEA, LIGHT HEADEDNESS, MICROCYTIC ANEMIA, MIGRAINE, EDEMA, INFLAMMATION, DACRYOADENITIS, DIARRHEA, HYPOTENSION, PYURIA, SYNCOPE AND DYSMENORRHEA. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND PARACETAMOL (ACETAMINOPHEN). 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 ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN ("ABDOMINAL AREA"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANT INFORMATION: ESSURE CONFIRMATION TEST CONDUCTED REPORTED AS NO . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): 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 : ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-AUG-2019: PFS RECEIVED. LOT NUMBER, CONCOMITANT MEDICATIONS AND CONCOMITANT CONDITIONS ADDED. EVENTS : ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTION, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH, ABDOMINAL AREA PAIN 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712193 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 952109 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| EPHEDRINE| EPHEDRINE| EPHEDRINE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| ACETAMINOPHEN| DEPO PROVERA| IBUPROFEN |