Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: IMPLANT BACKED UP AND BLOOD WAS BACKING UP INTO UTERUS'), URETERIC PERFORATION ('URETER PERFORATION'), SEPSIS ('INFECTION (OTHERS) DESCRIBE: SEPSIS REQUIRING HOSPITALIZATION POST HYSTERECTOMY AND URETER PERFORATION'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)'), MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') AND UTERINE HAEMORRHAGE ('BLOOD WAS BACKING UP INTO UTERUS') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY IN (B)(6) 2011, BLEED IN LUTEAL CYST, BILIARY COLIC AND PARATUBAL CYST. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN : PELVIC"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND MIGRAINE ("MIGRAINES/HEADACHES"). IN 2011, THE PATIENT EXPERIENCED MENOPAUSE ("HORMONAL CHANGES DESCRIBE: MENOPAUSAL CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED URETERIC PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SEPSIS (SERIOUSNESS CRITERION HOSPITALIZATION), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION ¿ ADENOMYOSIS"), OVARIAN CYST ("OVARIAN CYST") AND POST-TRAUMATIC STRESS DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROID"). THE PATIENT WAS TREATED WITH SURGERY (MULTIPLE SURGERIES FOR URETER REPAIR RESULTING FROM PREFORMATION S/P HYSTERECTOMY, TOTAL HYSTERECTOMY, UNILATERAL SALPINGO-OOPHORECTOMY ¿ RIGHT SIDED AND ABLATION). ESSURE WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, URETERIC PERFORATION, SEPSIS, VAGINAL HAEMORRHAGE, MENORRHAGIA, UTERINE HAEMORRHAGE, PELVIC PAIN, DYSMENORRHOEA, FATIGUE, MIGRAINE, ADENOMYOSIS, OVARIAN CYST, POST-TRAUMATIC STRESS DISORDER, UTERINE LEIOMYOMA AND MENOPAUSE HAD NOT RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, DEVICE DISLOCATION, DYSMENORRHOEA, FATIGUE, MENOPAUSE, MENORRHAGIA, MIGRAINE, OVARIAN CYST, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, SEPSIS, URETERIC PERFORATION, UTERINE HAEMORRHAGE, UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD: ADENOMYOSIS, OVARIAN CYST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-AUG-2019: PFS AND MR RECEIVED: PREVIOUSLY REPORTED EVENT "INJURY" WAS REPLACED WITH PAIN. NEW EVENTS WERE ADDED - ¿ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), URETER PERFORATION, INFECTION (OTHERS) DESCRIBE: SEPSIS, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: IMPLANT BACKED UP, BLOOD WAS BACKING UP INTO UTERUS, DYSMENORRHEA (CRAMPING), FATIGUE, MIGRAINES/HEADACHES, REPRODUCTIVE SYSTEM DISORDER OR CONDITION ¿ ADENOMYOSIS, OVARIAN CYST, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD, FIBROID, PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST, HORMONAL CHANGES DESCRIBE: MENOPAUSAL CHANGES¿. REPORTER INFORMATION AND PATIENT HISTORY WERE ADDED. 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-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.