ESSURE
Report
- Report Number
- 2951250-2019-06834
- Event Type
- Injury
- Date Received
- September 17, 2019
- Date of Event
- February 1, 2010
- Report Date
- May 21, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN') AND ENDOMETRITIS ('CHRONIC ENDOMETRITIS') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 (19-10-2004, 02-02-2007, 14-01-2008, 01-01-2010), PRETERM LABOR, APPENDECTOMY, ABDOMINAL EXPLORATION AND FIBROIDS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR ALLERGY: AMOXICILLIN AND PENICILLIN; FOR PREVENT PREGNANCY: MIRENA FROM JANUARY 2009 TO JANUARY 2010 AND DEPO SHOT FROM JANUARY 2008 TO JANUARY 2009. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED PREGNANCY WITH MIRENA AND DEPO SHOT. CONCURRENT CONDITIONS INCLUDED ANXIETY, DEPRESSION, HYPERLIPIDEMIA, BACK PAIN, PELVIC PAIN, ENDOMETRIOSIS, BIPOLAR I DISORDER, VAGINAL DISCHARGE, MENOMETRORRHAGIA, MENOMETRORRHAGIA, DYSMENORRHEA, OVARIAN TORSION, MENSES IRREGULAR, BREAST TENDERNESS, CERVICAL INTRAEPITHELIAL NEOPLASIA III, LOOP ELECTROSURGICAL EXCISION PROCEDURE, FALLOPIAN TUBE OBSTRUCTION, BULKY UTERUS, ADHESION, SEIZURES, NEUROMUSCULAR DISORDER NOS, TIA, CEREBROVASCULAR ACCIDENT NOS, ENDOCERVICITIS, NABOTHIAN CYST, PARAKERATOSIS, CERVICITIS HUMAN PAPILLOMA VIRUS, ENDOCERVICAL SQUAMOUS METAPLASIA, URINARY TRACT INFECTION, LOWER ABDOMINAL TENDERNESS, ACUTE VAGINITIS, OVARIAN CYST, VULVOVAGINITIS, THYROID ENLARGED AND SYSTEMIC INFLAMMATORY RESPONSE SYNDROME. FAMILY HISTORY INCLUDED DEPRESSION (MOTHER). CONCOMITANT PRODUCTS INCLUDED PROMETHAZINE FOR NAUSEA AS WELL AS CELECOXIB (CELEXA) SINCE (B)(6) 2012, CITALOPRAM SINCE (B)(6) 2012, IBUPROFEN SINCE JANUARY 2010 AND TRAZODONE HYDROCHLORIDE (DESYREL) SINCE (B)(6) 2012. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"), NAUSEA ("NAUSEA"), MIGRAINE ("MIGRAINES / HEADACHES"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL INFECTION"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEED"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("BACK PAIN"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, VAGINAL INFECTION, URINARY TRACT INFECTION AND VAGINAL DISCHARGE HAD RESOLVED AND THE ENDOMETRITIS, NAUSEA, MIGRAINE, VULVOVAGINAL MYCOTIC INFECTION, DEPRESSION, ANXIETY AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, ENDOMETRITIS, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, NAUSEA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS PER THIS FOLLOW UP INFORMATION, SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST (DISCREPANCY). DISCREPANT INFORMATION REGARDING REMOVAL: PFS RECEIVED ON 07AGO2019 STATES ESSURE WAS NOT REMOVED AND SHE WAS NOT PLANNING REMOVAL.PFS RECEIVED ON (B)(6) 2019 INFORMS REMOVAL BY FULL HYSTERECTOMY ON (B)(6) 2016. AS PER PATIENT NOTES OF (B)(6) 2017, PATIENT UNDERWENT LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY FOR FIBROIDS. PLAINTIFF HAD PREVIOUS PREGNANCY ON MIRENA WHICH HAS BEEN CAPTURED UNDER CASE (B)(4). PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, PSYCH INJURY, URINARY PROBLEMS. 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: VAGINAL BLEEDING AND ABDOMINAL PAIN CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ENDOMETRITIS. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN') AND ENDOMETRITIS ('CHRONIC ENDOMETRITIS') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6)2004, (B)(6)2007, (B)(6)2008, (B)(6)2010), PRETERM LABOR, APPENDECTOMY, ABDOMINAL EXPLORATION AND FIBROIDS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR ALLERGY: AMOXICILLIN AND PENICILLIN; FOR PREVENT PREGNANCY: MIRENA FROM (B)(6) 2009 TO (B)(6) 2010 AND DEPO SHOT FROM (B)(6) 2008 TO (B)(6) 2009. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED PREGNANCY WITH MIRENA AND DEPO SHOT. CONCURRENT CONDITIONS INCLUDED ANXIETY, DEPRESSION, HYPERLIPIDEMIA, BACK PAIN, PELVIC PAIN, ENDOMETRIOSIS, BIPOLAR I DISORDER, VAGINAL DISCHARGE, MENOMETRORRHAGIA, MENOMETRORRHAGIA, DYSMENORRHEA, OVARIAN TORSION, MENSES IRREGULAR, BREAST TENDERNESS, CERVICAL INTRAEPITHELIAL NEOPLASIA III, LOOP ELECTROSURGICAL EXCISION PROCEDURE, FALLOPIAN TUBE OBSTRUCTION, BULKY UTERUS, ADHESION, SEIZURES, NEUROMUSCULAR DISORDER NOS, TIA, CEREBROVASCULAR ACCIDENT NOS, ENDOCERVICITIS, NABOTHIAN CYST, PARAKERATOSIS, CERVICITIS HUMAN PAPILLOMA VIRUS, ENDOCERVICAL SQUAMOUS METAPLASIA, URINARY TRACT INFECTION, LOWER ABDOMINAL TENDERNESS, ACUTE VAGINITIS, OVARIAN CYST, VULVOVAGINITIS, THYROID ENLARGED AND SYSTEMIC INFLAMMATORY RESPONSE SYNDROME. FAMILY HISTORY INCLUDED DEPRESSION (MOTHER). CONCOMITANT PRODUCTS INCLUDED PROMETHAZINE FOR NAUSEA AS WELL AS CELECOXIB (CELEXA) SINCE (B)(6) 2012, CITALOPRAM SINCE (B)(6) 2012, IBUPROFEN SINCE (B)(6) 2010 AND TRAZODONE HYDROCHLORIDE (DESYREL) SINCE (B)(6) 2012. ON (B)(6)2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"), NAUSEA ("NAUSEA"), MIGRAINE ("MIGRAINES / HEADACHES"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL INFECTION"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEED"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("BACK PAIN"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, VAGINAL INFECTION, URINARY TRACT INFECTION AND VAGINAL DISCHARGE HAD RESOLVED AND THE ENDOMETRITIS, NAUSEA, MIGRAINE, VULVOVAGINAL MYCOTIC INFECTION, DEPRESSION, ANXIETY AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, ENDOMETRITIS, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, NAUSEA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS PER THIS FOLLOW UP INFORMATION, SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST (DISCREPANCY). DISCREPANT INFORMATION REGARDING REMOVAL: PFS RECEIVED ON (B)(6)2019 STATES ESSURE WAS NOT REMOVED AND SHE WAS NOT PLANNING REMOVAL.PFS RECEIVED ON (B)(6)2019 INFORMS REMOVAL BY FULL HYSTERECTOMY ON (B)(6)2016. AS PER PATIENT NOTES OF (B)(6)2017, PATIENT UNDERWENT LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY FOR FIBROIDS. PLAINTIFF HAD PREVIOUS PREGNANCY ON MIRENA WHICH HAS BEEN CAPTURED UNDER CASE- (B)(4.) PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, PSYCH INJURY, URINARY PROBLEMS. 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: VAGINAL BLEEDING AND ABDOMINAL PAIN CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ENDOMETRITIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-APR-2021: MEDICAL RECORD RECEIVED. EVENT ADDED: ENDOMETRITIS. REPORTERS INFORMATION AND MEDICAL HISTORY WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEED') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 (19-10-2004, 02-02-2007, 14-01-2008, 01-01-2010), PRETERM LABOR, APPENDECTOMY, ABDOMINAL EXPLORATION AND FIBROIDS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: MIRENA FROM (B)(6) 2009 TO (B)(6) 2010 AND DEPO SHOT FROM (B)(6) 2008 TO (B)(6) 2009. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED PREGNANCY WITH MIRENA AND DEPO SHOT. CONCURRENT CONDITIONS INCLUDED ANXIETY, DEPRESSION, HYPERLIPIDEMIA, BACK PAIN, PELVIC PAIN, ENDOMETRIOSIS, BIPOLAR I DISORDER, VAGINAL DISCHARGE, MENOMETRORRHAGIA, MENOMETRORRHAGIA, DYSMENORRHEA, OVARIAN TORSION, MENSES IRREGULAR, BREAST TENDERNESS, CERVICAL INTRAEPITHELIAL NEOPLASIA III, LOOP ELECTROSURGICAL EXCISION PROCEDURE, FALLOPIAN TUBE OBSTRUCTION, BULKY UTERUS, ADHESION, SEIZURES, NEUROMUSCULAR DISORDER NOS, TIA, CEREBROVASCULAR ACCIDENT NOS, ENDOCERVICITIS, NABOTHIAN CYST, PARAKERATOSIS, (B)(6), ENDOCERVICAL SQUAMOUS METAPLASIA, URINARY TRACT INFECTION, LOWER ABDOMINAL TENDERNESS, ACUTE VAGINITIS AND OVARIAN CYST. FAMILY HISTORY INCLUDED DEPRESSION (MOTHER). CONCOMITANT PRODUCTS INCLUDED PROMETHAZINE FOR NAUSEA AS WELL AS CELECOXIB (CELEXA) SINCE (B)(6) 2012, CITALOPRAM SINCE (B)(6) 2012, IBUPROFEN SINCE (B)(6) 2010 AND TRAZODONE HYDROCHLORIDE (DESYREL) SINCE (B)(6) 2012. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), NAUSEA ("NAUSEA"), MIGRAINE ("MIGRAINES / HEADACHES"), VULVOVAGINAL MYCOTIC INFECTION ("VAGINAL INFECTION"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("BACK PAIN"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), VAGINAL INFECTION ("VAGINAL INFECTION"), URINARY TRACT INFECTION ("UTI") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, VAGINAL INFECTION, URINARY TRACT INFECTION AND VAGINAL DISCHARGE HAD RESOLVED AND THE NAUSEA, MIGRAINE, VULVOVAGINAL MYCOTIC INFECTION, DEPRESSION, ANXIETY AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS PER THIS FOLLOW UP INFORMATION, SHE DIDN¿T UNDERGO AN ESSURE CONFIRMATION TEST (DISCREPANCY). DISCREPANT INFORMATION REGARDING REMOVAL: PFS RECEIVED ON "07AGO2019" STATES ESSURE WAS NOT REMOVED AND SHE WAS NOT PLANNING REMOVAL. PFS RECEIVED ON 05SEP2019 INFORMS REMOVAL BY FULL HYSTERECTOMY ON (B)(6) 2016. AS PER PATIENT NOTES OF (B)(6) 2017, PATIENT UNDERWENT LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY FOR FIBROIDS. PLAINTIFF HAD PREVIOUS PREGNANCY ON MIRENA WHICH HAS BEEN CAPTURED UNDER CASE- (B)(4). 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: VAGINAL BLEEDING AND ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-SEP-2019: PFS RECEIVED: NEW EVENTS ADDED: "DYSMENORRHEA (CRAMPING), BACK PAIN, GENERAL ABNORMAL BLEED, PSYCH INJURY, UTI, VAGINAL INFECTION, VAGINAL DISCHARGE". OUTCOME OF EVENTS, "PELVIC/ABDOMINAL PAIN, VAGINAL BLEEDING AND MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)" WERE UPDATED TO "RECOVERED/RESOLVED". PATIENT'S DEMOGRAPHICS WERE ADDED. PRODUCT INDICATION UPDATED. ESSURE INSERTION WAS UPDATED AND REMOVAL DATE WAS ADDED (FULL HYSTERECTOMY WAS PERFORMED). NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 |
|---|---|---|---|---|---|---|---|
| 869586 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other| R | CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CITALOPRAM| CITALOPRAM| CITALOPRAM| DESYREL| DESYREL| DESYREL| IBUPROFEN| IBUPROFEN| IBUPROFEN| PROMETHAZINE| PROMETHAZINE| PROMETHAZINE |