ESSURE
Report
- Report Number
- 2951250-2020-00453
- Event Type
- Injury
- Date Received
- January 16, 2020
- Date of Event
- March 30, 2015
- Report Date
- October 11, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING/ABNORMAL BLEEDING') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862109- NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VON WILLEBRAND'S DISEASE, HIDRADENITIS SUPPURATIVA, FOLLICULITIS, SCIATICA, VAGINITIS, MENOMETRORRHAGIA AND UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA, FLAGYL 550MG, DIFLUCAN AND DESMOPRESSIN. CONCOMITANT PRODUCTS INCLUDED CLINDAMYCIN, DESMOPRESSIN, DOCUSATE SODIUM (COLACE), ETHINYLESTRADIOL;LEVONORGESTREL (NORDETTE), FLUCONAZOLE (DIFLUCAN), HYDROCODONE, IBUPROFEN, METRONIDAZOLE, PARACETAMOL (ACETAMINOPHEN), RIFAMPICIN (RIFAMPIN) AND SULFAMETHOXAZOLE;TRIMETHOPRIM (SEPTRA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)/CRAMPS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). IN OCTOBER 2014, THE PATIENT EXPERIENCED VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("CHRONIC PAIN/PELVIC PAIN/PAIN") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 2 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED BASEDOW'S DISEASE ("AUTOIMMUNE DISORDER TYPE OF DISORDER: HYPERTHYROIDISM"). IN (B)(6) 2018, THE PATIENT UNDERWENT TOOTH EXTRACTION ("DENTAL PROBLEMS/ TOOTH EXTRACTION"). IN (B)(6) 2019, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES") AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL INFECTION ("VAGINAL INFECTION"), MIGRAINE ("MIGRAINES"), BACTERIAL INFECTION ("BACTERIAL INFECTIONS"), THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE NEOPLASM ("TUMORS") AND TERATOMA ("TERATOMAS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT ABLATION ON (B)(6) 2015). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, DYSMENORRHOEA, VAGINAL INFECTION, VAGINAL DISCHARGE, NEOPLASM, TERATOMA, MIGRAINE, BACTERIAL INFECTION, ABDOMINAL DISTENSION, THE LAST EPISODE OF ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, BASEDOW'S DISEASE, HOT FLUSH, TOOTH EXTRACTION, DYSPAREUNIA, FATIGUE, BACTERIAL VAGINOSIS, ALOPECIA, NAUSEA, VISION BLURRED AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, BACTERIAL INFECTION, BACTERIAL VAGINOSIS, BASEDOW'S DISEASE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HOT FLUSH, MENORRHAGIA, MIGRAINE, NAUSEA, NEOPLASM, PELVIC PAIN, TERATOMA, TOOTH EXTRACTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS DISCREPANCY NOTED IN DATE OF INSERTION ??-???-2014, (B)(6) 2013 PATIENT RECEIVED TREATMENT FOR- PAIN, BLEEDING, BLADDER/URINARY PROBLEMS, ABNORMAL BLEEDING, CRAMPS, MIGRAINES, BACTERIAL INFECTIONS, BLOATING, ABDOMINAL PAIN CURRENT WEIGHT 203 LBS. FINDING¿S: LEFT COIL 3, RIGHT COIL-03. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2012: UNKNOWN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JAN-2020: ¿UPDATE OF INFORMATION (BATCH IS NOT VALID).¿ 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 HEAVY MENSTRUAL BLEEDING ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)'), GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING/ABNORMAL BLEEDING'), PELVIC PAIN ('CHRONIC PAIN/PELVIC PAIN/PAIN') AND DEVICE BREAKAGE ('RECEIVED IN THE CONTAINER ARE TWO SILVER METAL COILS AND TWO SILVER METAL WIRES') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862109- NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VON WILLEBRAND'S DISEASE, HIDRADENITIS SUPPURATIVA, FOLLICULITIS, SCIATICA, VAGINITIS, MENOMETRORRHAGIA AND UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA, FLAGYL 550MG, DIFLUCAN AND DESMOPRESSIN. CONCOMITANT PRODUCTS INCLUDED CLINDAMYCIN, DESMOPRESSIN, DOCUSATE SODIUM (COLACE), ETHINYLESTRADIOL;LEVONORGESTREL (NORDETTE), FLUCONAZOLE (DIFLUCAN), HYDROCODONE, IBUPROFEN, METRONIDAZOLE, PARACETAMOL (ACETAMINOPHEN), RIFAMPICIN (RIFAMPIN) AND SULFAMETHOXAZOLE;TRIMETHOPRIM (SEPTRA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENNORHEA(CRAMPING)/CRAMPS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 2 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED BASEDOW'S DISEASE ("AUTOIMMUNE DISORDER TYPE OF DISORDER: HYPERTHYROIDISM"). IN (B)(6) 2018, THE PATIENT UNDERWENT TOOTH EXTRACTION ("DENTAL PROBLEMS/ TOOTH EXTRACTION"). IN (B)(6) 2019, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES") AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL INFECTION ("VAGINAL INFECTION"), MIGRAINE ("MIGRAINES"), BACTERIAL INFECTION ("BACTERIAL INFECTIONS"), THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE NEOPLASM ("TUMORS") AND TERATOMA ("TERATOMAS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH BILATERAL ESSURE REMOVAL AND UNDERWENT ABLATION ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE HEAVY MENSTRUAL BLEEDING, GENITAL HAEMORRHAGE, PELVIC PAIN, DEVICE BREAKAGE, DYSMENORRHOEA, VAGINAL INFECTION, VAGINAL DISCHARGE, NEOPLASM, TERATOMA, MIGRAINE, BACTERIAL INFECTION, ABDOMINAL DISTENSION, THE LAST EPISODE OF ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, BASEDOW'S DISEASE, HOT FLUSH, TOOTH EXTRACTION, DYSPAREUNIA, FATIGUE, BACTERIAL VAGINOSIS, ALOPECIA, NAUSEA, VISION BLURRED AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, BACTERIAL INFECTION, BACTERIAL VAGINOSIS, BASEDOW'S DISEASE, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, HOT FLUSH, MIGRAINE, NAUSEA, NEOPLASM, PELVIC PAIN, TERATOMA, TOOTH EXTRACTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS DISCREPANCY NOTED IN DATE OF INSERTION 2014, (B)(6) 2013 PATIENT RECEIVED TREATMENT FOR- PAIN, BLEEDING, BLADDER/URINARY PROBLEMS, ABNORMAL BLEEDING, CRAMPS, MIGRAINES, BACTERIAL INFECTIONS, BLOATING, ABDOMINAL PAIN CURRENT WEIGHT 203 LBS. FINDING¿S: LEFT COIL 3, RIGHT COIL-03. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2012: UNKNOWN. PATHOLOGY TEST - ON (B)(6) 2021: GROSS DESCRIPTION: LEFT RIGHT FALLOPIAN TUBES: RECEIVED IN FIXATIVE AS PATIENT¿S NAME LABELED LEFT AND RIGHT FALLOPIAN TUBES ARE TWO UNORIENTED, FIMBRIATED FALLOPIAN TUBES. THE FIRST TUBE (INKED GREEN) MEASURES 6.7 CM IN LENGTH BY 0.8 CM IN DIAMETER AND IS REMARKABLE FOR A 0.6 CM CLEAR FLUID-FILLED PARATUBAL CYST. THE SECOND TUBE (INKED BLUE) MEASURES 6.2 CM IN LENGTH BY 0.7 CM IN DIAMETER AND IS REMARKABLE FOR A 0.9 CM CLEAR FLUID-FILLED PARATUBAL CYST. ALSO RECEIVED IN THE SAME CONTAINER ARE TWO SILVER METAL WIRES MEASURING 15.5 CM IN LENGTH BY LESS THAN 0.1 CM IN DIAMETER AND 17 CM IN LENGTH BY LESS THAN 0.1 CM IN DIAMETER. LAST RECEIVED IN THE CONTAINER ARE TWO SILVER METAL COILS MEASURING 2 CM IN LENGTH BY 0.2 CM IN DIAMETER AND 3.5 CM IN LENGTH BY 0.2 CM IN DIAMETER. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2021: MR RECEIVED. ESSURE REMOVAL WAS ADDED. REPORTER ADDED. NEWEVENT ADDED- DEVICE BREAKAGE. WE HAVE RECEIVED NOT VALID LOT NUMBER IN THIS CASE. 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 MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING/ABNORMAL BLEEDING') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862109) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VON WILLEBRAND'S DISEASE, HIDRADENITIS SUPPURATIVA, FOLLICULITIS, SCIATICA, VAGINITIS, MENOMETRORRHAGIA AND UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA, FLAGYL 550MG, DIFLUCAN AND DESMOPRESSIN. CONCOMITANT PRODUCTS INCLUDED CLINDAMYCIN, DESMOPRESSIN, DOCUSATE SODIUM (COLACE), ETHINYLESTRADIOL;LEVONORGESTREL (NORDETTE), FLUCONAZOLE (DIFLUCAN), HYDROCODONE, IBUPROFEN, METRONIDAZOLE, PARACETAMOL (ACETAMINOPHEN), RIFAMPICIN (RIFAMPIN) AND SULFAMETHOXAZOLE;TRIMETHOPRIM (SEPTRA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)/CRAMPS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("CHRONIC PAIN/PELVIC PAIN/PAIN") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 2 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED HYPERTHYROIDISM ("AUTOIMMUNE DISORDER TYPE OF DISORDER: HYPERTHYROIDISM"). IN (B)(6) 2018, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS/ TOOTH EXTRACTION"). IN (B)(6) 2019, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES") AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL INFECTION ("VAGINAL INFECTION"), MIGRAINE ("MIGRAINES"), BACTERIAL INFECTION ("BACTERIAL INFECTIONS"), THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE NEOPLASM ("TUMORS") AND TERATOMA ("TERATOMAS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT ABLATION ON (B)(6) 2015). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, DYSMENORRHOEA, VAGINAL INFECTION, VAGINAL DISCHARGE, NEOPLASM, TERATOMA, MIGRAINE, BACTERIAL INFECTION, ABDOMINAL DISTENSION, THE LAST EPISODE OF ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, HYPERTHYROIDISM, HOT FLUSH, TOOTH DISORDER, DYSPAREUNIA, FATIGUE, BACTERIAL VAGINOSIS, ALOPECIA, NAUSEA, VISION BLURRED AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, BACTERIAL INFECTION, BACTERIAL VAGINOSIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HOT FLUSH, HYPERTHYROIDISM, MENORRHAGIA, MIGRAINE, NAUSEA, NEOPLASM, PELVIC PAIN, TERATOMA, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2014, (B)(6) 2013 PATIENT RECEIVED TREATMENT FOR- PAIN, BLEEDING, BLADDER/URINARY PROBLEMS, ABNORMAL BLEEDING, CRAMPS, MIGRAINES, BACTERIAL INFECTIONS, BLOATING, ABDOMINAL PAIN CURRENT WEIGHT (B)(6) LBS. FINDING¿S: LEFT COIL 3, RIGHT COIL-03. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2012: UNKNOWN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENOMETRORRHAGIA, ABNORMAL UTERINE BLEEDING CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL DISCHARGE, DYSMENORRHOEA, BACTERIAL VAGINOSIS, PELVIC PAIN, MENORRHAGIA, VON WILLEBRAND DISORDER, ABDOMINAL PAIN, WEIGHT GAIN QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-DEC-2019: PFS AND MR RECEIVED. REPORTER INFORMATION, LOT NUMBER, CONCOMITANT DRUG, MEDICAL HISTORY, HISTORICAL DRUG ADDED. EVENTS: ABNORMAL BLEEDING (VAGINAL), AUTOIMMUNE DISORDER TYPE OF DISORDER: HYPERTHYROIDISM, HORMONAL CHANGES DESCRIBE: HOT FLASHES, DENTAL PROBLEMS, DYSPAREUNIA, FATIGUE, BACTERIAL VAGINOSIS, HAIR LOSS, NAUSEA, VISION/EYE PROBLEMS TYPE: BLURRED VISION, WEIGHT GAIN 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 RELEVANT 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 |
|---|---|---|---|---|---|---|---|
| 59656 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 862109- NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other| R | ACETAMINOPHEN.| ACETAMINOPHEN.| ACETAMINOPHEN.| CLINDAMYCIN.| CLINDAMYCIN.| CLINDAMYCIN.| COLACE.| COLACE.| COLACE.| DESMOPRESSIN.| DESMOPRESSIN.| DESMOPRESSIN.| DIFLUCAN.| DIFLUCAN.| DIFLUCAN.| HYDROCODONE.| HYDROCODONE.| HYDROCODONE.| IBUPROFEN.| IBUPROFEN.| IBUPROFEN.| METRONIDAZOLE.| METRONIDAZOLE.| METRONIDAZOLE.| NORDETTE.| NORDETTE.| NORDETTE.| RIFAMPIN.| RIFAMPIN.| RIFAMPIN.| SEPTRA.| SEPTRA.| SEPTRA. |