Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('PERFORATION (UTERUS) / FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE'), EMBEDDED DEVICE ('GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: COIL EMBEDDED IN COLON, COIL EMBEDDED IN ABDOMEN, ONE COIL WAS STILL EMBEDDED IN MY PELVIS'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ABDOMEN, MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: ABDOMEN, THE COIL ON THE RIGHT FALLOPIAN TUBE MIGRATED OUT OF FALLOPIAN'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') AND POST PROCEDURAL HAEMORRHAGE ('SOME BLEEDING ON RIGHT AFTER PLACEMENT') 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 OVERWEIGHT. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PROGESTERONE AND PARAGARD IUD. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL ),"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA),"), ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL ALLERGY"), FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), MUSCULAR WEAKNESS ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MUSCLE WEAKNESS,"), TREMOR ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: TREMORS"), ERYTHEMA ("RASHES OR SKIN CONDITIONS TYPE: REDNESS ON FACE AND NECK"), HYPOTHYROIDISM ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: HYPOTHYROID RECTOCELE PROLAPSE") AND RECTOCELE ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: HYPOTHYROID RECTOCELE PROLAPSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED POST PROCEDURAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VULVOVAGINAL PAIN ("VAGINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, EMBEDDED DEVICE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, ALLERGY TO METALS, FIBROMYALGIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MUSCULAR WEAKNESS, TREMOR, ERYTHEMA, HYPOTHYROIDISM, RECTOCELE AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, ERYTHEMA, FATIGUE, FIBROMYALGIA, GENITAL HAEMORRHAGE, HYPOTHYROIDISM, MENORRHAGIA, MUSCULAR WEAKNESS, PELVIC PAIN, POST PROCEDURAL HAEMORRHAGE, RECTOCELE, TREMOR, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). HYSTEROSALPINGOGRAM - ON (B)(6) 2013: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED) FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES MIGRATION OF ESSURE DEVICE. THE COIL ON THE RIGHT FALLOPIAN TUBE MIGRATED OUT OF FALLOPIAN TUBE INTO ABDOMEN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-2019: PFS RECEIVED REPORTER INFORMATION WAS ADDED. CASE BECOME INCIDENT. NEW EVENT ADDED UTERINE PERFORATION, EMBEDDED DEVICE, DEVICE DISLOCATION, GENITAL BLEEDING, PELVIC PAIN FEMALE, VAGINAL BLEEDING, MENORRHAGIA, NICKEL ALLERGY, FIBROMYALGIA, FATIGUE, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MUSCLE WEAKNESS, TREMOR, REDNESS ON FACE AND NECK, HYPOTHYROID, RECTOCELE, VAGINAL PAIN. SEVERITY ADDED PELVIC PAIN FEMALE, VAGINAL PAIN. HISTORICAL DRUGS AND LAB TEST WAS 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.