ESSURE
Report
- Report Number
- 2951250-2019-08497
- Event Type
- Injury
- Date Received
- September 26, 2019
- Date of Event
- April 1, 2016
- Report Date
- June 11, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE'), DEVICE EXPULSION ('MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE:LEFT OSTIA AND FUNDUS') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (, MENORRHAGIA') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D13376,C95070,D133376 -INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSMENORRHEA, PELVIC PAIN, DYSPAREUNIA, DEPRESSION, ANXIETY, ASTHMA, TENOSYNOVITIS, RHINITIS, DIARRHEA, INSOMNIA, RHINOSINUSITIS, CONSTIPATION, COMMON COLD, UPPER RESPIRATORY INFECTION, JOINT PAIN, CHOLECYSTECTOMY, UTERINE BLEEDING, VERTIGO, DIZZINESS, GIDDINESS AND ENDOMETRIOSIS. CONCOMITANT PRODUCTS INCLUDED BUDESONIDE FOR ASTHMA, ESOMEPRAZOLE MAGNESIUM FOR GERD AND IRRITABLE BOWEL SYNDROME AS WELL AS INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"). ON(B)(6) 2018, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), PELVIC PAIN ("PHYSICAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING/DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA"), ANXIETY ("PSYCHOLOGY INJURY/ANXIETY/MENTAL ANGUISH"), VAGINAL DISCHARGE ("BLADDER/URINARY PROBLEMS: VAGINAL . DISCHARGE"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, "), DEPRESSION ("PSYCHOLOGY INJURY/DEPRESSION,") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH AMITRIPTYLINE, IBUPROFEN, NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (OPERATIVE LAPAROSCOPY WITH BILATERAL SALPINGECTOMY HYSTEROSCOPY, REMOVAL OF IUD AND DIALATION AND CURRETAGE). ESSURE WAS REMOVED ON(B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, ANXIETY, VAGINAL HAEMORRHAGE, DEPRESSION AND ALOPECIA OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL INFECTION, VAGINAL DISCHARGE, HEADACHE AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE(B)(6) 2015 00 DISCREPANCY NOTED IN ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY- (B)(6) 2016 RESULTS: RIGHT OCCLUSION ONLY. A TOTAL OF 1 COIL ON THE LEFT AND 3 COILS ON THE RIGHT REMAINED IN THE UTERINE CAVITY SHE RECEIVED TREATMENT FOR PAIN PELVIC/ ABDOMINAL, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEEDING, PSYCH INJURY, MIGRATION, BLADDER/URINARY PROBLEMS: VAGINAL INFECTION, VAGINAL DISCHARGE, OTHER INJURIES/SYMPTOMS: HEADACHES, .WEIGHT GAIN THE METAL FILAMENT HAS A SOMEWHAT ZIG-ZAG PATTERN, COIL FRAGMENTS THAT HAS BEEN STRETCHED . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ABDOMEN SCAN - ON AN UNKNOWN DATE: 1. NORMAL PELVIC ULTRASOUND. INCIDENTAL NOTE OF A FUNCTIONAL RIGHT OVARIAN CYST. 2. INTRAUTERINE DEVICE IN PLACE.. COMPUTERISED TOMOGRAM ABDOMEN - ON AN UNKNOWN DATE: MILDLY PROMINENT DIAMETER OF THE APPENDIX BUT NO CONVINCING FEATURES OF ACUTE APPENDICITIS. FLUID IN THE PELVIS UNRELATED TO THE APPENDIX. 2. SMALL AMOUNT OF MILDLY COMPLEX FLUID IN THE PELVIS, POSSIBLY TRACE BLOOD PRODUCTS. MILDLY PROMINENT CYSTIC STRUCTURE IN THE LEFT; ADNEXA POSSIBLE HEMORRHAGIC CYST. FURTHER EVALUATION COULD BE OBTAINED WITH PELVIC ULTRASOUND IF WARRANTED. 3. IUD IN PLACE. 4. STATUS POST CHOLECYSTECTOMY; ON AN UNKNOWN DATE: IMPRESSION: NO ACUTE INFLAMMATORY PROCESS IN THE ABDOMEN OR PELVIS. LEFT OVARIAN CORPUS LUTEUM CYST. HYSTEROSALPINGOGRAM - ON(B)(6) 2016: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED FIRST TEST SHOWED ONLY RIGHT FALLOPIAN TUBE CLOSED, THE LEFT TUBE WAS STILL OPEN.; ON (B)(6) : OCCLUSION OF THE RIGHT FALLOPIAN TUBE, BUT PATENCY OF THE LEFT FALLOPIAN TUBE.. PATHOLOGY TEST - ON(B)(6) 2018: SPECIMEN'S) RECEIVED A: ENDOMETRIUM, CURETTAGE B: ESSURE COILS C: FALLOPIAN TUBES, BILATERAL D: INTRAUTERINE DEVICE FINAL PATHOLOGIC DIAGNOSIS UTERUS, ENDOMETRIUM, CURETTAGE: WEAKLY PROLIFERATIVE ENDOMETRIUM WITH BREAKDOWN FRAGMENTS OF BENIGN ENDOCERVICAL AND SQUAMOUS EPITHELIUM NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY ESSURE COILS, REMOVAL: METAL COILS CONSISTENT WITH ESSURE COILS(GROSS ONLY) FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY: NO HISTOPATHOLOGIC ABNORMALITY INTRAUTERINE DEVICE, REMOVAL: T-SHAPED PLASTIC CONSISTENT WITH INTRAUTERINE DEVICE (GROSS ONLY) CLINICAL HISTORY: PELVIC PAIN. GROSS DESCRIPTION: THE SECOND CONTAINER IS RECEIVED IN FORMALIN, LABELED WITH THE PATIENT¿S NAME. DATE OF BIRTH, AND ESSURE COIL, AND CONSISTS OF FOUR. METAL FOREIGN BODIES, THREE OF WHICH ARE COILED IN APPEARANCE, THE THIRD APPEARS TO BE A LONG METAL FILAMENT, WHICH MAY REPRESENT ONE OF THE COIL FRAGMENTS THAT HAS BEEN STRETCHED, AND MEASURES 30 CM IN LENGTH X LESS THAN 0.1CM IN WIDTH, THE OTHER FRAGMENT OF METAL IS COILED INTO A TANGLE. THIS FRAGMENT MEASURES 0,7 X 0.5 X 0.4 CM. THE THIRD FRAGMENT REPRESENTS A TIGHTLY COILED WIRE, WHICH MEASURES 3,5X 0.2 X 0,2 CM. THE FINAL FRAGMENT IS A METALLIC FILAMENT WHICH MEASURES 7.5 CM IN LENGTH X LESS THAN 0;1 CM IN WIDTH. THE METAL FILAMENT HAS A SOMEWHAT ZIG-ZAG PATTERN.. ULTRASOUND DOPPLER - ON AN UNKNOWN DATE: APPROPRIATELY POSITIONED INTRAUTERINE DEVICE; OTHERWISE, UNREMARKABLE PELVIC SONOGRAM.. ULTRASOUND PELVIS - ON AN UNKNOWN DATE: UTERUS SIZE: 9.5 X 3.4 X 5.6 CM. MASSES: NONE. ENDOMETRIUM: NORMAL. ENDOMETRIAL THICKNESS: 10 MM. ADNEXA ADNEXA: NORMAL. RIGHT OVARY SIZE: 3.3 X 1.6 X 2.3 CM. LEFT OVARY SIZE: 2.8 X 2.6 X 1.3 CM. FREE FLUID: NONE. OTHER FINDINGS: AN INTRAUTERINE DEVICE IS IN PLACE. IMPRESSION: NORMAL PELVIC ULTRASOUND. AN INTRAUTERINE DEVICE IS IN PLACE.. X-RAY - ON (B)(6) 2016: STATUS POST ESSURE PROCEDURE WITH PATENT LEFT FALLOPIAN TUBE THE RIGHT FALLOPIAN TUBE IS OCCLUDED. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS : PELVIC INFLAMMATORY DISEASE CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS PELVIC PAIN, DEPRESSION, ANXIETY, PELVIC INFLAMMATORY DISEASE, ABDOMINAL PAIN LOT #NUMBER REPORTED D133376 IS INVALID. LOT NUMBER: C95070 PRODUCTION DATE 2014-08-11 EXPIRATION DATE 2017-08-31 LOT NUMBER: D13376. PRODUCTION DATE 2014-09-23 EXPIRATION DATE 2017-09-28 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON(B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC 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 INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE'), DEVICE EXPULSION ('MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT OSTIA AND FUNDUS') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (, MENORRHAGIA') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D13376,C95070) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSMENORRHEA, PELVIC PAIN, DYSPAREUNIA, DEPRESSION, ANXIETY, ASTHMA, TENOSYNOVITIS, RHINITIS, DIARRHEA, INSOMNIA, RHINOSINUSITIS, CONSTIPATION, COMMON COLD, UPPER RESPIRATORY INFECTION, JOINT PAIN, CHOLECYSTECTOMY, UTERINE BLEEDING, VERTIGO, DIZZINESS, GIDDINESS AND ENDOMETRIOSIS. CONCOMITANT PRODUCTS INCLUDED BUDESONIDE FOR ASTHMA, ESOMEPRAZOLE MAGNESIUM FOR GERD AND IRRITABLE BOWEL SYNDROME AS WELL AS INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), PELVIC PAIN ("PHYSICAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING/DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA"), ANXIETY ("PSYCHOLOGY INJURY/ANXIETY/MENTAL ANGUISH"), VAGINAL DISCHARGE ("BLADDER/URINARY PROBLEMS: VAGINAL. DISCHARGE"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL,"), DEPRESSION ("PSYCHOLOGY INJURY/DEPRESSION,") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH AMITRIPTYLINE, IBUPROFEN, NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (OPERATIVE LAPAROSCOPY WITH BILATERAL SALPINGECTOMY HYSTEROSCOPY, REMOVAL OF IUD AND DIALATION AND CURRETAGE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, ANXIETY, VAGINAL HAEMORRHAGE, DEPRESSION AND ALOPECIA OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL INFECTION, VAGINAL DISCHARGE, HEADACHE AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE- (B)(6) 2015 00. DISCREPANCY NOTED IN ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY- (B)(6) 2016 RESULTS: RIGHT OCCLUSION ONLY. A TOTAL OF 1 COIL ON THE LEFT AND 3 COILS ON THE RIGHT REMAINED IN THE UTERINE CAVITY SHE RECEIVED TREATMENT FOR PAIN PELVIC/ ABDOMINAL, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEEDING, PSYCH INJURY, MIGRATION, BLADDER/URINARY PROBLEMS: VAGINAL INFECTION, VAGINAL DISCHARGE, OTHER INJURIES/SYMPTOMS: HEADACHES, .WEIGHT GAIN THE METAL FILAMENT HAS A SOMEWHAT ZIG-ZAG PATTERN, COIL FRAGMENTS THAT HAS BEEN STRETCHED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ABDOMEN SCAN - ON AN UNKNOWN DATE: 1. NORMAL PELVIC ULTRASOUND. INCIDENTAL NOTE OF A FUNCTIONAL RIGHT OVARIAN CYST. 2. INTRAUTERINE DEVICE IN PLACE. COMPUTERISED TOMOGRAM ABDOMEN - ON AN UNKNOWN DATE: MILDLY PROMINENT DIAMETER OF THE APPENDIX BUT NO CONVINCING FEATURES OF ACUTE APPENDICITIS. FLUID IN THE PELVIS UNRELATED TO THE APPENDIX. 2. SMALL AMOUNT OF MILDLY COMPLEX FLUID IN THE PELVIS, POSSIBLY TRACE BLOOD PRODUCTS. MILDLY PROMINENT CYSTIC STRUCTURE IN THE LEFT; ADNEXA POSSIBLE HEMORRHAGIC CYST. FURTHER EVALUATION COULD BE OBTAINED WITH PELVIC ULTRASOUND IF WARRANTED. 3. IUD IN PLACE. 4. STATUS POST CHOLECYSTECTOMY; ON AN UNKNOWN DATE: IMPRESSION: NO ACUTE INFLAMMATORY PROCESS IN THE ABDOMEN OR PELVIS. LEFT OVARIAN CORPUS LUTEUM CYST. HYSTEROSALPINGOGRAM - ON (B)(6) 2016: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED FIRST TEST SHOWED ONLY RIGHT FALLOPIAN TUBE CLOSED, THE LEFT TUBE WAS STILL OPEN.; ON (B)(6) 2016: OCCLUSION OF THE RIGHT FALLOPIAN TUBE, BUT PATENCY OF THE LEFT FALLOPIAN TUBE. PATHOLOGY TEST - ON (B)(6) 2018: SPECIMEN'S) RECEIVED. A: ENDOMETRIUM, CURETTAGE, B: ESSURE COILS, C: FALLOPIAN TUBES, BILATERAL, D: INTRAUTERINE DEVICE, FINAL PATHOLOGIC DIAGNOSIS, UTERUS, ENDOMETRIUM, CURETTAGE: WEAKLY PROLIFERATIVE ENDOMETRIUM WITH BREAKDOWN FRAGMENTS OF BENIGN ENDOCERVICAL AND SQUAMOUS EPITHELIUM NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY ESSURE COILS, REMOVAL: METAL COILS CONSISTENT WITH ESSURE COILS(GROSS ONLY) FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY: NO HISTOPATHOLOGIC ABNORMALITY INTRAUTERINE DEVICE, REMOVAL: T-SHAPED PLASTIC CONSISTENT WITH INTRAUTERINE DEVICE (GROSS ONLY) CLINICAL HISTORY: PELVIC PAIN. GROSS DESCRIPTION: THE SECOND CONTAINER IS RECEIVED IN FORMALIN, LABELED WITH THE PATIENT¿S NAME. DATE OF BIRTH, AND ESSURE COIL, AND CONSISTS OF FOUR. METAL FOREIGN BODIES, THREE OF WHICH ARE COILED IN APPEARANCE, THE THIRD APPEARS TO BE A LONG METAL FILAMENT, WHICH MAY REPRESENT ONE OF THE COIL FRAGMENTS THAT HAS BEEN STRETCHED, AND MEASURES 30 CM IN LENGTH X LESS THAN 0.1CM IN WIDTH, THE OTHER FRAGMENT OF METAL IS COILED INTO A TANGLE. THIS FRAGMENT MEASURES 0,7 X 0.5 X 0.4 CM. THE THIRD FRAGMENT REPRESENTS A TIGHTLY COILED WIRE, WHICH MEASURES 3,5X 0.2 X 0,2 CM. THE FINAL FRAGMENT IS A METALLIC FILAMENT WHICH MEASURES 7.5 CM IN LENGTH X LESS THAN 0;1 CM IN WIDTH. THE METAL FILAMENT HAS A SOMEWHAT ZIG-ZAG PATTERN.. ULTRASOUND DOPPLER - ON AN UNKNOWN DATE: APPROPRIATELY POSITIONED INTRAUTERINE DEVICE; OTHERWISE, UNREMARKABLE PELVIC SONOGRAM.. ULTRASOUND PELVIS - ON AN UNKNOWN DATE: UTERUS SIZE: 9.5 X 3.4 X 5.6 CM. MASSES: NONE. ENDOMETRIUM: NORMAL. ENDOMETRIAL THICKNESS: 10 MM. ADNEXA ADNEXA: NORMAL. RIGHT OVARY SIZE: 3.3 X 1.6 X 2.3 CM. LEFT OVARY SIZE: 2.8 X 2.6 X 1.3 CM. FREE FLUID: NONE. OTHER FINDINGS: AN INTRAUTERINE DEVICE IS IN PLACE. IMPRESSION: NORMAL PELVIC ULTRASOUND. AN INTRAUTERINE DEVICE IS IN PLACE.. X-RAY - ON (B)(6) 2016: STATUS POST ESSURE PROCEDURE WITH PATENT LEFT FALLOPIAN TUBE THE RIGHT FALLOPIAN TUBE IS OCCLUDED. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS : PELVIC INFLAMMATORY DISEASE. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS PELVIC PAIN, DEPRESSION, ANXIETY, PELVIC INFLAMMATORY DISEASE, ABDOMINAL PAIN. LOT #NUMBER REPORTED D133376 IS INVALID. LOT NUMBER: C95070 MANUFACTURE DATE: 2014-08 EXPIRATION DATE: 2017-08. LOT NUMBER: D13376 MANUFACTURE DATE: 2014-09 EXPIRATION DATE: 2017-09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. EVENT "HAIR LOSS" 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 INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE'), DEVICE EXPULSION ('MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE:LEFT OSTIA AND FUNDUS'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (, MENORRHAGIA') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D13376,C95070) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSMENORRHEA, PELVIC PAIN, DYSPAREUNIA, DEPRESSION, ANXIETY, ASTHMA, TENOSYNOVITIS, RHINITIS, DIARRHEA, INSOMNIA, RHINOSINUSITIS, CONSTIPATION, COMMON COLD, UPPER RESPIRATORY INFECTION, JOINT PAIN, CHOLECYSTECTOMY, UTERINE BLEEDING, VERTIGO, DIZZINESS, GIDDINESS AND ENDOMETRIOSIS. CONCOMITANT PRODUCTS INCLUDED BUDESONIDE FOR ASTHMA, ESOMEPRAZOLE MAGNESIUM FOR GERD AND IRRITABLE BOWEL SYNDROME AS WELL AS INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING/DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA"), ANXIETY ("PSYCHOLOGY INJURY/ANXIETY/MENTAL ANGUISH"), VAGINAL DISCHARGE ("BLADDER/URINARY PROBLEMS: VAGINAL . DISCHARGE"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, ") AND DEPRESSION ("PSYCHOLOGY INJURY/DEPRESSION,") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH AMITRIPTYLINE, IBUPROFEN, NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (OPERATIVE LAPAROSCOPY WITH BILATERAL SALPINGECTOMY HYSTEROSCOPY, REMOVAL OF IUD AND DIALATION AND CURRETAGE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, ANXIETY, VAGINAL HAEMORRHAGE AND DEPRESSION OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL INFECTION, VAGINAL DISCHARGE, HEADACHE AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE - (B)(6) 2015 00 DISCREPANCY NOTED IN ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY- (B)(6) 2016 RESULTS: RIGHT OCCLUSION ONLY. A TOTAL OF 1 COIL ON THE LEFT AND 3 COILS ON THE RIGHT REMAINED IN THE UTERINE CAVITY SHE RECEIVED TREATMENT FOR PAIN PELVIC/ ABDOMINAL, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEEDING, PSYCH INJURY, MIGRATION, BLADDER/URINARY PROBLEMS: VAGINAL INFECTION, VAGINAL DISCHARGE, OTHER INJURIES/SYMPTOMS: HEADACHES, .WEIGHT GAIN THE METAL FILAMENT HAS A SOMEWHAT ZIG-ZAG PATTERN, COIL FRAGMENTS THAT HAS BEEN STRETCHED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ABDOMEN SCAN - ON AN UNKNOWN DATE: 1. NORMAL PELVIC ULTRASOUND. INCIDENTAL NOTE OF A FUNCTIONAL RIGHT OVARIAN CYST. 2. INTRAUTERINE DEVICE IN PLACE. COMPUTERISED TOMOGRAM ABDOMEN - ON AN UNKNOWN DATE: MILDLY PROMINENT DIAMETER OF THE APPENDIX BUT NO CONVINCING FEATURES OF ACUTE APPENDICITIS. FLUID IN THE PELVIS UNRELATED TO THE APPENDIX. 2. SMALL AMOUNT OF MILDLY COMPLEX FLUID IN THE PELVIS, POSSIBLY TRACE BLOOD PRODUCTS. MILDLY PROMINENT CYSTIC STRUCTURE IN THE LEFT; ADNEXA POSSIBLE HEMORRHAGIC CYST. FURTHER EVALUATION COULD BE OBTAINED WITH PELVIC ULTRASOUND IF WARRANTED. 3. IUD IN PLACE. 4. STATUS POST CHOLECYSTECTOMY; ON AN UNKNOWN DATE: IMPRESSION: NO ACUTE INFLAMMATORY PROCESS IN THE ABDOMEN OR PELVIS. LEFT OVARIAN CORPUS LUTEUM CYST. HYSTEROSALPINGOGRAM - ON (B)(6) 2016: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED FIRST TEST SHOWED ONLY RIGHT FALLOPIAN TUBE CLOSED, THE LEFT TUBE WAS STILL OPEN.; ON (B)(6) 2016: OCCLUSION OF THE RIGHT FALLOPIAN TUBE, BUT PATENCY OF THE LEFT FALLOPIAN TUBE.. PATHOLOGY TEST - ON (B)(6) 2018: SPECIMEN'S) RECEIVED A: ENDOMETRIUM, CURETTAGE. B: ESSURE COILS. C: FALLOPIAN TUBES, BILATERAL. D: INTRAUTERINE DEVICE. FINAL PATHOLOGIC DIAGNOSIS. UTERUS, ENDOMETRIUM, CURETTAGE: WEAKLY PROLIFERATIVE ENDOMETRIUM WITH BREAKDOWN FRAGMENTS OF BENIGN ENDOCERVICAL AND SQUAMOUS EPITHELIUM NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY. ESSURE COILS, REMOVAL: METAL COILS CONSISTENT WITH ESSURE COILS(GROSS ONLY). FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY: NO HISTOPATHOLOGIC ABNORMALITY. INTRAUTERINE DEVICE, REMOVAL: T-SHAPED PLASTIC CONSISTENT WITH INTRAUTERINE DEVICE (GROSS ONLY). CLINICAL HISTORY: PELVIC PAIN. GROSS DESCRIPTION: THE SECOND CONTAINER IS RECEIVED IN FORMALIN, LABELED WITH THE PATIENT¿S NAME. DATE OF BIRTH, AND ESSURE COIL, AND CONSISTS OF FOUR. METAL FOREIGN BODIES, THREE OF WHICH ARE COILED IN APPEARANCE, THE THIRD APPEARS TO BE A LONG METAL FILAMENT, WHICH MAY REPRESENT ONE OF THE COIL FRAGMENTS THAT HAS BEEN STRETCHED, AND MEASURES 30 CM IN LENGTH X LESS THAN 0.1CM IN WIDTH, THE OTHER FRAGMENT OF METAL IS COILED INTO A TANGLE. THIS FRAGMENT MEASURES 0,7 X 0.5 X 0.4 CM. THE THIRD FRAGMENT REPRESENTS A TIGHTLY COILED WIRE, WHICH MEASURES 3,5X 0.2 X 0,2 CM. THE FINAL FRAGMENT IS A METALLIC FILAMENT WHICH MEASURES 7.5 CM IN LENGTH X LESS THAN 0;1 CM IN WIDTH. THE METAL FILAMENT HAS A SOMEWHAT ZIG-ZAG PATTERN.. ULTRASOUND DOPPLER - ON AN UNKNOWN DATE: APPROPRIATELY POSITIONED INTRAUTERINE DEVICE; OTHERWISE, UNREMARKABLE PELVIC SONOGRAM.. ULTRASOUND PELVIS - ON AN UNKNOWN DATE: UTERUS SIZE: 9.5 X 3.4 X 5.6 CM. MASSES: NONE. ENDOMETRIUM: NORMAL. ENDOMETRIAL THICKNESS: 10 MM. ADNEXA ADNEXA: NORMAL. RIGHT OVARY SIZE: 3.3 X 1.6 X 2.3 CM. LEFT OVARY SIZE: 2.8 X 2.6 X 1.3 CM. FREE FLUID: NONE. OTHER FINDINGS: AN INTRAUTERINE DEVICE IS IN PLACE. IMPRESSION: NORMAL PELVIC ULTRASOUND. AN INTRAUTERINE DEVICE IS IN PLACE.. X-RAY - ON (B)(6) 2016: STATUS POST ESSURE PROCEDURE WITH PATENT LEFT FALLOPIAN TUBE THE RIGHT FALLOPIAN TUBE IS OCCLUDED. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS : PELVIC INFLAMMATORY DISEASE CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS PELVIC PAIN, DEPRESSION, ANXIETY, PELVIC INFLAMMATORY DISEASE, ABDOMINAL PAIN. LOT #NUMBER REPORTED D133376 IS INVALID. LOT NUMBER: C95070, MANUFACTURE DATE: 2014-08, EXPIRATION DATE: 2017-08. LOT NUMBER: D13376, MANUFACTURE DATE: 2014-09, EXPIRATION DATE: 2017-09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-OCT-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE'), DEVICE DISLOCATION ('MIGRATION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE:LEFT OSTIA AND FUNDUS'), MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (, MENORRHAGIA') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D133376, C95070) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSMENORRHEA, PELVIC PAIN, DYSPAREUNIA, DEPRESSION, ANXIETY, ASTHMA, TENOSYNOVITIS, RHINITIS, DIARRHEA, INSOMNIA, RHINOSINUSITIS, CONSTIPATION, COMMON COLD, UPPER RESPIRATORY INFECTION, JOINT PAIN, CHOLECYSTECTOMY, UTERINE BLEEDING, VERTIGO, DIZZINESS, GIDDINESS AND ENDOMETRIOSIS. CONCOMITANT PRODUCTS INCLUDED BUDESONIDE FOR ASTHMA, ESOMEPRAZOLE MAGNESIUM FOR GERD AND IRRITABLE BOWEL SYNDROME AS WELL AS INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING/DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA"), ANXIETY ("PSYCHOLOGY INJURY/ANXIETY/MENTAL ANGUISH"), VAGINAL DISCHARGE ("BLADDER/URINARY PROBLEMS: VAGINAL . DISCHARGE"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, ") AND DEPRESSION ("PSYCHOLOGY INJURY/DEPRESSION,") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH AMITRIPTYLINE, IBUPROFEN, NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (OPERATIVE LAPAROSCOPY WITH BILATERAL SALPINGECTOMY HYSTEROSCOPY, REMOVAL OF IUD AND DIALATION AND CURRETAGE). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE DISLOCATION, ANXIETY, VAGINAL HAEMORRHAGE AND DEPRESSION OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL INFECTION, VAGINAL DISCHARGE, HEADACHE AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE (B)(6) 2015 00 DISCREPANCY NOTED IN ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY- (B)(6)2016 RESULTS: RIGHT OCCLUSION ONLY. A TOTAL OF 1 COIL ON THE LEFT AND 3 COILS ON THE RIGHT REMAINED IN THE UTERINE CAVITY SHE RECEIVED TREATMENT FOR PAIN PELVIC/ ABDOMINAL, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEEDING, PSYCH INJURY, MIGRATION, BLADDER/URINARY PROBLEMS: VAGINAL INFECTION, VAGINAL DISCHARGE, OTHER INJURIES/SYMPTOMS: HEADACHES, .WEIGHT GAIN THE METAL FILAMENT HAS A SOMEWHAT ZIG-ZAG PATTERN, COIL FRAGMENTS THAT HAS BEEN STRETCHED DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ABDOMEN SCAN - ON AN UNKNOWN DATE: 1. NORMAL PELVIC ULTRASOUND. INCIDENTAL NOTE OF A FUNCTIONAL RIGHT OVARIAN CYST. 2. INTRAUTERINE DEVICE IN PLACE. COMPUTERISED TOMOGRAM ABDOMEN - ON AN UNKNOWN DATE: MILDLY PROMINENT DIAMETER OF THE APPENDIX BUT NO CONVINCING FEATURES OF ACUTE APPENDICITIS. FLUID IN THE PELVIS UNRELATED TO THE APPENDIX.. 2. SMALL AMOUNT OF MILDLY COMPLEX FLUID IN THE PELVIS, POSSIBLY TRACE BLOOD PRODUCTS. MILDLY PROMINENT. CYSTIC STRUCTURE IN THE LEFT; ADNEXA POSSIBLE HEMORRHAGIC CYST. FURTHER EVALUATION COULD BE OBTAINED WITH PELVIC ULTRASOUND IF WARRANTED. 3. IUD IN PLACE. 4. STATUS POST CHOLECYSTECTOMY; ON AN UNKNOWN DATE: IMPRESSION: NO ACUTE INFLAMMATORY PROCESS IN THE ABDOMEN OR PELVIS. LEFT OVARIAN CORPUS LUTEUM CYST. HYSTEROSALPINGOGRAM - ON (B)(6) 2016: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED FIRST TEST SHOWED ONLY RIGHT FALLOPIAN TUBE CLOSED, THE LEFT TUBE WAS STILL OPEN.; ON (B)(6) 2016: OCCLUSION OF THE RIGHT FALLOPIAN TUBE, BUT PATENCY OF THE LEFT FALLOPIAN TUBE.. PATHOLOGY TEST - ON (B)(6) 2018: SPECIMEN'S) RECEIVED. A: ENDOMETRIUM, CURETTAGE. B: ESSURE COILS. C: FALLOPIAN TUBES, BILATERAL. D: INTRAUTERINE DEVICE. FINAL PATHOLOGIC DIAGNOSIS UTERUS, ENDOMETRIUM, CURETTAGE: WEAKLY PROLIFERATIVE ENDOMETRIUM WITH BREAKDOWN FRAGMENTS OF BENIGN ENDOCERVICAL AND SQUAMOUS EPITHELIUM NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY ESSURE COILS, REMOVAL: METAL COILS CONSISTENT WITH ESSURE COILS(GROSS ONLY) FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY: NO HISTOPATHOLOGIC ABNORMALITY INTRAUTERINE DEVICE, REMOVAL: T-SHAPED PLASTIC CONSISTENT WITH INTRAUTERINE DEVICE (GROSS ONLY) CLINICAL HISTORY: PELVIC PAIN. GROSS DESCRIPTION: THE SECOND CONTAINER IS RECEIVED IN FORMALIN, LABELED WITH THE PATIENT¿S NAME. DATE OF BIRTH, AND ESSURE COIL, AND CONSISTS OF FOUR. METAL FOREIGN BODIES, THREE OF WHICH ARE COILED IN APPEARANCE, THE THIRD APPEARS TO BE A LONG METAL FILAMENT, WHICH MAY REPRESENT ONE OF THE COIL FRAGMENTS THAT HAS BEEN STRETCHED, AND MEASURES 30 CM IN LENGTH X LESS THAN 0.1CM IN WIDTH, THE OTHER FRAGMENT OF METAL IS COILED INTO A TANGLE. THIS FRAGMENT MEASURES 0,7 X 0.5 X 0.4 CM. THE THIRD FRAGMENT REPRESENTS A TIGHTLY COILED WIRE, WHICH MEASURES 3,5X 0.2 X 0,2 CM. THE FINAL FRAGMENT IS A METALLIC FILAMENT WHICH MEASURES 7.5 CM IN LENGTH X LESS THAN 0;1 CM IN WIDTH. THE METAL FILAMENT HAS A SOMEWHAT ZIG-ZAG PATTERN.. ULTRASOUND DOPPLER - ON AN UNKNOWN DATE: APPROPRIATELY POSITIONED INTRAUTERINE DEVICE; OTHERWISE, UNREMARKABLE PELVIC SONOGRAM.. ULTRASOUND PELVIS - ON AN UNKNOWN DATE: UTERUS SIZE: 9.5 X 3.4 X 5.6 CM. MASSES: NONE. ENDOMETRIUM: NORMAL. ENDOMETRIAL THICKNESS: 10 MM. ADNEXA ADNEXA: NORMAL. RIGHT OVARY SIZE: 3.3 X 1.6 X 2.3 CM. LEFT OVARY SIZE: 2.8 X 2.6 X 1.3 CM. FREE FLUID: NONE. OTHER FINDINGS: AN INTRAUTERINE DEVICE IS IN PLACE. IMPRESSION: NORMAL PELVIC ULTRASOUND. AN INTRAUTERINE DEVICE IS IN PLACE.. X-RAY - ON (B)(6) 2016: STATUS POST ESSURE PROCEDURE WITH PATENT LEFT FALLOPIAN TUBE THE RIGHT FALLOPIAN TUBE IS OCCLUDED. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS : PELVIC INFLAMMATORY DISEASE CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS PELVIC PAIN, DEPRESSION, ANXIETY, PELVIC INFLAMMATORY DISEASE, ABDOMINAL PAIN MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS AND MR RECEIVED: ABNORMAL BLEEDING (VAGINAL),DEPRESSION ADDED. EVENT PSYCHOLOGICAL TRAUMA PT WAS UPDATED TO ANXIETY /MENTAL ANGUISH. LAB DATA, MEDICAL HISTORY, TREATMENT, CONCOMITANT DRUGS, HISTORICAL DRUGS, LOT NUMBER 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 DEVICE DISLOCATION ('MIGRATION') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), PSYCHOLOGICAL TRAUMA ("PSYCHOLOGY INJURY"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL INFECTION"), VAGINAL DISCHARGE ("BLADDER/URINARY PROBLEMS: VAGINAL . DISCHARGE") AND HEADACHE ("HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, VAGINAL INFECTION, VAGINAL DISCHARGE, HEADACHE AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, VAGINAL DISCHARGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE- (B)(6) 2015 00 DISCREPANCY NOTED IN ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY- (B)(6) 2016 RESULTS: RIGHT OCCLUSION ONLY. SHE RECEIVED TREATMENT FOR PAIN PELVIC/ ABDOMINAL, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEEDING, PSYCH INJURY, MIGRATION, BLADDER/URINARY PROBLEMS: VAGINAL INFECTION, VAGINAL DISCHARGE, OTHER INJURIES/SYMPTOMS: HEADACHES, WEIGHT GAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2019: NEW PFS RECEIVED- NEW EVENTS ADDED -PAIN: PELVIC/ ABDOMINAL, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEEDING, PSYCH INJURY, MIGRATION, BLADDER/URINARY PROBLEMS: VAGINAL INFECTION, VAGINAL DISCHARGE, OTHER INJURIES/SYMPTOMS: HEADACHES, WEIGHT GAIN. OUTCOME OF EVENTS PAIN, BLEEDING, BLADDER/URINARY,OTHER FROM UNKNOWN TO RECOVERED/RESOLVED WERE UPDATED. PRODUCT INDICATION WAS UPDATED. 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 |
|---|---|---|---|---|---|---|---|
| 920095 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | D13376,C95070,D133376 -INVALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R | BUDESONIDE| BUDESONIDE| BUDESONIDE| BUDESONIDE| ESOMEPRAZOLE MAGNESIUM| ESOMEPRAZOLE MAGNESIUM| ESOMEPRAZOLE MAGNESIUM| ESOMEPRAZOLE MAGNESIUM| IUD NOS| IUD NOS| IUD NOS| IUD NOS |