ESSURE
Report
- Report Number
- 2951250-2019-04253
- Event Type
- Injury
- Date Received
- July 29, 2019
- Report Date
- October 31, 2019
- 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
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('FURTHER SECTIONING OF THE MYOMETRIUM REVEALS TWO METALLIC INSERTS PARTIALLY EMBEDDED IN THE MYOMETRIUM') AND DEVICE DISLOCATION ('ON ULTRASOUND, WE ARE NOT ABLE TO VISUALIZE THE ESSURE / POSSIBILITY OF MIGRATION OF THE RIGHT ESSURE BIRTH CONTROL DEVICE / THE COIL ON THE RIGHT SIDE MAY HAVE MIGRATED FROM THE FALLOPIAN TUBE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIOSIS, PYELONEPHRITIS, LOOP ELECTROSURGICAL EXCISION PROCEDURE, LAPAROSCOPY (2006, 2007), MENINGITIS, HERPES SIMPLEX, HYPERTHYROIDISM, PREGNANCY (B)(6)2015), HEMORRHOIDS, MULTI GRAVIDA, PARITY 4 AND GENITAL HERPES. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA FROM 2009 TO (B)(6)2010. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, HYPERTHYROIDISM, GERD, HYPERTENSION, NAUSEA, SORE THROAT, TACHYCARDIA, DEHYDRATION, SUPRAPUBIC PAIN, BACTERIAL VAGINOSIS, CERVICITIS, BACK PAIN, KNEE PAIN, HEMATOMA, HERNIA, RECTAL PAIN, FLANK PAIN, URINARY FREQUENCY, CYST REMOVAL (2013), THYROTOXICOSIS (2012), DIZZY, DIFFICULTY SLEEPING, ADENOMYOSIS, VAGINAL BLEEDING, ABDOMINAL DISTENSION, SHORTNESS OF BREATH, DYSURIA, MENSTRUAL CRAMP AND MENORRHAGIA. CONCOMITANT PRODUCTS INCLUDED FAMOTIDINE, IBUPROFEN SINCE (B)(6)2012, MACROGOL 3350 (MIRALAX), ONDANSETRON HYDROCHLORIDE (ZOFRAN), OXYCODONE HYDROCHLORIDE;PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) SINCE (B)(6)2012, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), PARACETAMOL (ACETAMINOPHEN), PROMETHAZINE, PROPRANOLOL AND THIAMAZOLE (METHIMAZOLE). ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN/ PELVIC AREA"), ABDOMINAL PAIN ("PAIN ABDOMINAL AREA"), MIGRAINE ("MIGRAINES/HEADACHES"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6)2012, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITIONS:- DEPRESSION"). IN (B)(6)2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("CRAMPING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND NAUSEA ("NAUSEA"). THE PATIENT WAS TREATED WITH ALPRAZOLAM, FLUOXETINE, PARACETAMOL (TYLENOL) AND SURGERY (TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6)2013. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, DEVICE DISLOCATION, ANXIETY, MIGRAINE, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, ALOPECIA AND DEPRESSION OUTCOME WAS UNKNOWN, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA AND NAUSEA WAS RESOLVING, THE ABDOMINAL PAIN LOWER HAD NOT RESOLVED AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, EMBEDDED DEVICE, FATIGUE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATES: (B)(6)2009, (B)(6)2012 CURRENT WEIGHT 195 LBS. INSERTION DETAILS: THE PATIENT¿S RIGHT TUBE HAD 1 COIL AT THE OSTIA. THE PATIENT'S LEFT TUBE HAD TWO COILS AT THE OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. CHEST X-RAY - ON (B)(6)2013: IMPRESSION: 1. NO ACUTE CARDIOPULMONARY DISEASE. COMPUTERISED TOMOGRAM PELVIS - ON (B)(6)2012: NO EVIDENCE OF A PELVIC ABSCESS SEEN. NO ACUTE INFLAMMATORY CHANGES SEEN IN THE ABDOMEN OR PELVIS; ON (B)(6)2013: POSSIBLE MIGRATION OF THE ESSURE COIL FROM THE RIGHT FALLOPIAN TUBE; ON (B)(6)2013: IMPRESSION: 1. SINCE EXAMINATION OF 3 DAYS AGO WAS FELT TO BE A PELVIC HEMATOMA IS UNCHANGED OR MINIMALLY LARGER THAN PREVIOUSLY NOTED. IT HAS MIXED INTERNAL DENSITY BUT HAS NOT LIQUEFIED. NO INTERNAL GAS IS SEEN. 2. THE APPENDIX ITSELF IS AGAIN DIFFICULT TO VISUALIZE IN ITS ENTIRETY WITH THE TIP COURSING TOWARD THIS PELVIC COLLECTION. THE PROXIMAL PORTION THE APPENDIX IS SOMEWHAT PROMINENT. 3. INTERVAL DEVELOPMENT OF SMALL RIGHT PLEURAL EFFUSION.; ON (B)(6)2013: IMPRESSION: 1. SMALL LEFT PERIANAL ABSCESS OR FISTULA SLIGHTLY SMALLER ON THE CURRENT EXAMINATION. 2. HYSTERECTOMY. 3. OTHERWISE NEGATIVE. HYSTEROSALPINGOGRAM - ON (B)(6)2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. RESULT: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6)2013: CHRONIC CERVITIS WITH SQUAMOUS METAPLASIA . ENDOMETRIOSIS; ON (B)(6)2013: UTERUS, CERVIX, HYSTERECTOMY: CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. MUCOSAL EROSIONS.. SPINAL X-RAY - ON (B)(6)2012: UNREMARKABLE TWO-VIEW LUMBAR SPINE. ULTRASOUND PELVIS - ON (B)(6)2012: NO ACUTE FINDINGS SEEN. SMALL VOLUME FREE FLUID.. X-RAY - ON (B)(6)2012: NO ACUTE TRAUMATIC PATHOLOGY DELINEATED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, NAUSEA, VAGINAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-OCT-2019: PFS RECEIVED. OUTCOME OF THE EVENT PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING) AND NAUSEA WERE CHANGED TO RECOVERING FROM NOT RECOVERED. REPORTER INFORMATION, MEDICAL HISTORY AND TREATMENT DRUG 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('FURTHER SECTIONING OF THE MYOMETRIUM REVEALS TWO METALLIC INSERTS PARTIALLY EMBEDDED IN THE MYOMETRIUM') AND DEVICE DISLOCATION ('ON ULTRASOUND, WE ARE NOT ABLE TO VISUALIZE THE ESSURE / POSSIBILITY OF MIGRATION OF THE RIGHT ESSURE BIRTH CONTROL DEVICE / THE COIL ON THE RIGHT SIDE MAY HAVE MIGRATED FROM THE FALLOPIAN TUBE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIOSIS, PYELONEPHRITIS, LOOP ELECTROSURGICAL EXCISION PROCEDURE, LAPAROSCOPY (2006, 2007), MENINGITIS, HERPES SIMPLEX, HYPERTHYROIDISM, PREGNANCY (B)(6) 2015), HEMORRHOIDS, MULTI GRAVIDA, PARITY 4 AND GENITAL HERPES. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, HYPERTHYROIDISM, GERD, HYPERTENSION, NAUSEA, SORE THROAT, TACHYCARDIA, DEHYDRATION, SUPRAPUBIC PAIN, BACTERIAL VAGINOSIS, CERVICITIS, BACK PAIN, KNEE PAIN, HEMATOMA, HERNIA, RECTAL PAIN, FLANK PAIN, URINARY FREQUENCY, CYST REMOVAL (2013), THYROTOXICOSIS (2012), DIZZY, DIFFICULTY SLEEPING, ADENOMYOSIS, VAGINAL BLEEDING, ABDOMINAL DISTENSION, SHORTNESS OF BREATH AND DYSURIA. CONCOMITANT PRODUCTS INCLUDED FAMOTIDINE, IBUPROFEN, MACROGOL 3350 (MIRALAX), ONDANSETRON HYDROCHLORIDE (ZOFRAN), OXYCODONE HYDROCHLORIDE;PARACETAMOL (OXYCODONE AND ACETAMINOPHEN), OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), PARACETAMOL (ACETAMINOPHEN), PROMETHAZINE, PROPRANOLOL AND THIAMAZOLE (METHIMAZOLE). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN APRIL 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN/ PELVIC AREA"), ABDOMINAL PAIN ("PAIN ABDOMINAL AREA"), MIGRAINE ("MIGRAINES/HEADACHES"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN MAY 2012, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITIONS:- DEPRESSION"). IN MARCH 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("CRAMPING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND NAUSEA ("NAUSEA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, DEVICE DISLOCATION, ANXIETY, MIGRAINE, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, ALOPECIA AND DEPRESSION OUTCOME WAS UNKNOWN, THE PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA AND NAUSEA HAD NOT RESOLVED AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, EMBEDDED DEVICE, FATIGUE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATES: JAN-2009, (B)(6) 2012 CURRENT WEIGHT 195 LBS. INSERTION DETAILS: THE PATIENT¿S RIGHT TUBE HAD 1 COIL AT THE OSTIA. THE PATIENT'S LEFT TUBE HAD TWO COILS AT THE OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. CHEST X-RAY - ON (B)(6) 2013: IMPRESSION: 1. NO ACUTE CARDIOPULMONARY DISEASE.. COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2012: NO EVIDENCE OF A PELVIC ABSCESS SEEN. NO ACUTE INFLAMMATORY CHANGES SEEN IN THE ABDOMEN OR PELVIS; ON (B)(6) 2013: POSSIBLE MIGRATION OF THE ESSURE COIL FROM THE RIGHT FALLOPIAN TUBE; ON (B)(6) 2013: IMPRESSION: 1. SINCE EXAMINATION OF 3 DAYS AGO WAS FELT TO BE A PELVIC HEMATOMA IS UNCHANGED OR MINIMALLY LARGER THAN PREVIOUSLY NOTED. IT HAS MIXED INTERNAL DENSITY BUT HAS NOT LIQUEFIED. NO INTERNAL GAS IS SEEN. 2. THE APPENDIX ITSELF IS AGAIN DIFFICULT TO VISUALIZE IN ITS ENTIRETY WITH THE TIP COURSING TOWARD THIS PELVIC COLLECTION. THE PROXIMAL PORTION THE APPENDIX IS SOMEWHAT PROMINENT. 3. INTERVAL DEVELOPMENT OF SMALL RIGHT PLEURAL EFFUSION.; ON (B)(6) 2013: IMPRESSION: 1. SMALL LEFT PERIANAL ABSCESS OR FISTULA SLIGHTLY SMALLER ON THE CURRENT EXAMINATION. 2. HYSTERECTOMY. 3. OTHERWISE NEGATIVE. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. RESULT: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2013: CHRONIC CERVITIS WITH SQUAMOUS METAPLASIA . ENDOMETRIOSIS; ON (B)(6) 2013: UTERUS, CERVIX, HYSTERECTOMY: CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. MUCOSAL EROSIONS.. SPINAL X-RAY - ON (B)(6) 2012: UNREMARKABLE TWO-VIEW LUMBAR SPINE. ULTRASOUND PELVIS - ON (B)(6) 2012: NO ACUTE FINDINGS SEEN. SMALL VOLUME FREE FLUID.. X-RAY - ON (B)(6) 2012: NO ACUTE TRAUMATIC PATHOLOGY DELINEATED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, NAUSEA, VAGINAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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-CONFORMANCE'S 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 EMBEDDED DEVICE ('FURTHER SECTIONING OF THE MYOMETRIUM REVEALS TWO METALLIC INSERTS PARTIALLY EMBEDDED IN THE MYOMETRIUM') AND DEVICE DISLOCATION ('ON ULTRASOUND, WE ARE NOT ABLE TO VISUALIZE THE ESSURE / POSSIBILITY OF MIGRATION OF THE RIGHT ESSURE BIRTH CONTROL DEVICE / THE COIL ON THE RIGHT SIDE MAY HAVE MIGRATED FROM THE FALLOPIAN TUBE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIOSIS, PYELONEPHRITIS, LOOP ELECTROSURGICAL EXCISION PROCEDURE, LAPAROSCOPY (2006, 2007), MENINGITIS, (B)(6), HYPERTHYROIDISM, PREGNANCY ((B)(6) 2015), HEMORRHOIDS, MULTI GRAVIDA, PARITY 4 AND (B)(6). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, HYPERTHYROIDISM, GERD, HYPERTENSION, NAUSEA, SORE THROAT, TACHYCARDIA, DEHYDRATION, SUPRAPUBIC PAIN, BACTERIAL VAGINOSIS, CERVICITIS, BACK PAIN, KNEE PAIN, HEMATOMA, HERNIA, RECTAL PAIN, FLANK PAIN, URINARY FREQUENCY, CYST REMOVAL (2013), THYROTOXICOSIS (2012), DIZZY, DIFFICULTY SLEEPING, ADENOMYOSIS, VAGINAL BLEEDING, ABDOMINAL DISTENSION, SHORTNESS OF BREATH AND DYSURIA. CONCOMITANT PRODUCTS INCLUDED FAMOTIDINE, IBUPROFEN, MACROGOL 3350 (MIRALAX), ONDANSETRON HYDROCHLORIDE (ZOFRAN), OXYCODONE HYDROCHLORIDE;PARACETAMOL (OXYCODONE AND ACETAMINOPHEN), OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), PARACETAMOL (ACETAMINOPHEN), PROMETHAZINE, PROPRANOLOL AND THIAMAZOLE (METHIMAZOLE). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN/ PELVIC AREA"), ABDOMINAL PAIN ("PAIN ABDOMINAL AREA"), MIGRAINE ("MIGRAINES/HEADACHES"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITIONS:- DEPRESSION"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("CRAMPING"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND NAUSEA ("NAUSEA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, DEVICE DISLOCATION, ANXIETY, MIGRAINE, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, ALOPECIA AND DEPRESSION OUTCOME WAS UNKNOWN, THE PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA AND NAUSEA HAD NOT RESOLVED AND THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, EMBEDDED DEVICE, FATIGUE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATES: (B)(6) 2009, (B)(6) 2012. CURRENT WEIGHT (B)(6). INSERTION DETAILS: THE PATIENT¿S RIGHT TUBE HAD 1 COIL AT THE OSTIA. THE PATIENT'S LEFT TUBE HAD TWO COILS AT THE OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.5 KG/SQM. CHEST X-RAY - ON (B)(6) 2013: IMPRESSION: NO ACUTE CARDIOPULMONARY DISEASE. COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2012: IMPRESSION- NO EVIDENCE OF A PELVIC ABSCESS SEEN. NO ACUTE INFLAMMATORY CHANGES SEEN IN THE ABDOMEN OR PELVIS; ON (B)(6) 2013: IMPRESSION: NO URINARY TRACT ABNORMALITIES. POSSIBLE MIGRATION OF THE ESSURE COIL FROM THE RIGHT FALLOPIAN TUBE. THE CLINICAL SIGNIFICANCE OF THIS IS UNKNOWN; ON (B)(6) 2013: IMPRESSION: SINCE EXAMINATION OF 3 DAYS AGO WAS FELT TO BE A PELVIC HEMATOMA IS UNCHANGED OR MINIMALLY LARGER THAN PREVIOUSLY NOTED. IT HAS MIXED INTERNAL DENSITY BUT HAS NOT LIQUEFIED. NO INTERNAL GAS IS SEEN. THE APPENDIX ITSELF IS AGAIN DIFFICULT TO VISUALIZE IN ITS ENTIRETY WITH THE TIP COURSING TOWARD THIS PELVIC COLLECTION. THE PROXIMAL PORTION THE APPENDIX IS SOMEWHAT PROMINENT. INTERVAL DEVELOPMENT OF SMALL RIGHT PLEURAL EFFUSION.; ON (B)(6) 2013: IMPRESSION: SMALL LEFT PERIANAL ABSCESS OR FISTULA SLIGHTLY SMALLER ON THE CURRENT EXAMINATION. HYSTERECTOMY. OTHERWISE NEGATIVE. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. RESULT: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2013: DIAGNOSIS- LEFT FALLOPIAN TUBE, UNILATERAL SALPINGECTOMY - BENIGN FALLOPIAN TUBE. UTERUS, CERVIX, HYSTERECTOMY- CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. MUCOSAL EROSIONS. UTERUS, ENDOMETRIUM, HYSTERECTOMY-WEAKLY PROLIFERATIVE ENDOMETRIUM UTERUS , MYOMETRIUM, HYSTERECTOMY- SEROSAL FIBROVASCULAR ADHESION¿S . FALLOPIAN TUBE, RIGHT, SALPINGECTOMY- BENIGN FALLOPIAN TUBE ,. OVARIES, BILATERAL OOPHORECTOMIES- OVARIAN SURFACE FIBRO VASCULAR ADHESION. FOLLICULAR CYST , INVOLUTING HEMORRHAGIC CORPUS LUTEUM CLINICAL HISTORY- ENDOMETRIOSIS SPECIMEN- LEFT FALLOPIAN TUBE, UTERUS WITH CERVIX, RIGHT FALLOPIAN TUBE AND OVARY; ON (B)(6) 2013: LEFT FALLOPIAN TUBE, UNILATERAL SALPINGECTOMY: BENIGN FALLOPIAN TUBE. UTERUS, CERVIX, HYSTERECTOMY: CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. MUCOSAL EROSIONS. UTERUS, ENDOMETRIUM, HYSTERECTOMY: WEAKLY PROLIFERATIVE ENDOMETRIUM. UTERUS, MYOMETRIUM, HYSTERECTOMY: SUPERFICIAL ADENOMYOSIS. UTERUS, SEROSA, HYSTERECTOMY: SEROSAL FIBROVASCULAR ADHESIONS. FALLOPIAN TUBE, RIGHT, SALPINGECTOMY: BENIGN FALLOPIAN TUBE. OVARIES, BILATERAL OOPHORECTOMIES: OVARIAN SURFACE FIBROVASCULAR ADHESIONS. FOLLICULAR CYST. INVOLUTING HEMORRHAGIC CORPUS LUTEUM. SPINAL X-RAY - ON (B)(6) 2012: IMPRESSION- UNREMARKABLE TWO-VIEW LUMBAR SPINE. ULTRASOUND PELVIS - ON (B)(6) 2012: IMPRESSION- NO ACUTE FINDINGS SEEN. SMALL VOLUME FREE FLUID.; ON (B)(6) 2012: IMPRESSION- NORMAL EXAMINATION. X-RAY - ON (B)(6) 2012: PELVIS: IMPRESSION- NO ACUTE TRAUMATIC PATHOLOGY DELINEATED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN, NAUSEA, VAGINAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUL-2019: PFS AND MR RECEIVED: CASE BECAME INCIDENT. LOT NO ADDED. NEW EVENTS - ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION & MENTAL ANGUISH, MIGRAINES / HEADACHES, NAUSEA, DYSMENORRHEA (CRAMPING), PAIN, VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN, HAIR LOSS, CRAMPING WERE ADDED. EVENT ADDED FROM MEDICAL RECORD ¿ ¿FURTHER SECTIONING OF THE MYOMETRIUM REVEALS TWO METALLIC INSERTS PARTIALLY EMBEDDED IN THE MYOMETRIUM, ON ULTRASOUND, WE ARE NOT ABLE TO VISUALIZE THE ESSURE / POSSIBILITY OF MIGRATION OF THE RIGHT ESSURE BIRTH CONTROL DEVICE / THE COIL ON THE RIGHT SIDE MAY HAVE MIGRATED FROM THE FALLOPIAN TUBE¿. OUTCOME OF EVENT ABNORMAL BLEEDING WAS UPDATED AS RECOVERED/RESOLVED AND PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND NAUSEA WAS UPDATED AS NOT RECOVERED / NOT RESOLVED. REPORTER¿S INFORMATION, PATIENT DEMOGRAPHY, MEDICAL HISTORY, CONCOMITANT CONDITION, LAB DATA, HISTORICAL DRUG, CONCOMITANT DRUGS 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 |
|---|---|---|---|---|---|---|---|
| 630980 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922606 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| FAMOTIDINE| FAMOTIDINE| FAMOTIDINE| IBUPROFEN| IBUPROFEN| IBUPROFEN| METHIMAZOLE| METHIMAZOLE| METHIMAZOLE| MIRALAX| MIRALAX| MIRALAX| OXYCODONE AND ACETAMINOPHEN| OXYCODONE AND ACETAMINOPHEN| OXYCODONE AND ACETAMINOPHEN| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PROMETHAZINE| PROMETHAZINE| PROMETHAZINE| PROPRANOLOL| PROPRANOLOL| PROPRANOLOL| ZOFRAN [ONDANSETRON HYDROCHLORIDE]| ZOFRAN [ONDANSETRON HYDROCHLORIDE]| ZOFRAN [ONDANSETRON HYDROCHLORIDE]| ACETAMINOPHEN| FAMOTIDINE| IBUPROFEN| METHIMAZOLE| MIRALAX| OXYCODONE AND ACETAMINOPHEN| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PROMETHAZINE| PROPRANOLOL| ZOFRAN [ONDANSETRON HYDROCHLORIDE] |