Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ('LOWER ABDOMINAL PAIN'), AUTOIMMUNE DISORDER ('AUTOIMMUNE DISORDER TYPE OF DISORDER: NOT SURE') AND SEIZURE ('SEIZURES') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY, BREAST FEEDING, (B)(6) INFECTION, ASTHMA, CONGESTIVE HEART FAILURE, ELECTIVE ABORTION, ANEMIA, POSTPARTUM DEPRESSION, SPONTANEOUS ABORTION, AUGMENTATION MAMMOPLASTY, COLPOSCOPY, SPIDER BITE, GRAVIDA II AND PARITY 3. CURRENT WEIGHT (B)(6) LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ALBUTEROL, PNV, MONISTAT, DIFLUCAN, GYNAZOLE AND ADVAIR. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, VULVAL ITCHING, VULVAL BURNING SENSATION, VAGINAL DISCHARGE, VAGINAL IRRITATION, ADENOMYOSIS AND MULTIPAROUS. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN) SINCE (B)(6) 2009, IBUPROFEN (MOTRIN), IBUPROFEN (SINGULAR), LORAZEPAM (ATIVAN), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), SALBUTAMOL SINCE 1999 AND TRAMADOL HYDROCHLORIDE (TRAMADOL) SINCE 2009. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2008, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2008, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BONE PAIN ("BONE PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), NERVE INJURY ("NERVE DAMAGE") AND ARTHRALGIA ("JOINT PAIN"). IN (B)(6) 2008, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND BLADDER DISORDER ("BLADDER PROBLEMS"). IN 2008, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION,"). IN (B)(6) 2008, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE,"). IN (B)(6) 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MIGRAINE ("MIGRAINE/ HEADACHES") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH ALPRAZOLAM (XANAX), AMITRIPTYLINE, ESOMEPRAZOLE, PREDNISONE, PREGABALIN (LYRICA), RIZATRIPTAN BENZOATE (MAXALT), STEROIDS, TOPIRAMATE (TOPAMAX) AND SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). ESSURE WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, AUTOIMMUNE DISORDER, MENORRHAGIA, SEIZURE, FEMALE SEXUAL DYSFUNCTION, BONE PAIN, ANXIETY, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, WEIGHT DECREASED, ALOPECIA, NERVE INJURY, ARTHRALGIA AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, BLADDER DISORDER, BONE PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, MIGRAINE, NAUSEA, NERVE INJURY, SEIZURE, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION- (B)(6) 2010, (B)(6) 2008 INSERTION DETAILS- RIGHT TUBAL OSTIA 2 COILS AND LEFT TUBAL OSTIA 7 COILS NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.1 KG/SQM. HYSTEROSALPINGOGRAM - IN 2008: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE DESCRIBED/CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSPAREUNIA , MENORRHAGIA, SEIZURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS+MR RECEIVED- NEW EVENTS ABNORMAL BLEEDING (MENORRHAGIA), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), DEPRESSION, AUTOIMMUNE DISORDER TYPE OF DISORDER: NOT SURE, URINARY PROBLEMS, BLADDER PROBLEMS, MIGRAINES / HEADACHES, NAUSEA, SEIZURES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, WEIGHT LOSS, HAIR LOSS, LOWER ABDOMINAL PAIN, BONE PAIN, JOINT PAIN, NERVE DAMAGE, ANXIETY WERE ADDED. EVENT INJURY UPDATED TO ABNORMAL BLEEDING (VAGINAL). NEW REPORTER, PATIENT INFORMATION, MEDICAL HISTORY, LAB DATA, HISTORICAL ,CONCOMITANT AND TREATMENT DRUG WERE ADDED. INCIDENT. 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.