Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN'), GENITAL HAEMORRHAGE ('BLEEDING, GENERAL ABNORMAL BLEEDING') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN AN ADULT 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 "NEVER HAD THE HSG THREE MONTHS AFTER IT WAS INSERTED, ESSURE CONFIRMATION TEST(S) CONDUCTED PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST" IN 2013. THE PATIENT'S MEDICAL HISTORY INCLUDED DELIVERY IN (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), METRORRHAGIA ("METORHAGIA (BLEEDING B/W PERIODS)"), ANAEMIA ("ANEMIA"), HYPERSENSITIVITY ("ALLERGY"), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEMS: UTI"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL INFECTION"), VAGINAL DISCHARGE ("BLADDER/URINARY PROBLEMS: VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), ALOPECIA ("HAIR LOSS, HAVE HAIR THAT COMES OUT BY THE HANDFULS"), TOOTH DISORDER ("DENTAL PROBLEMS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), VISUAL IMPAIRMENT ("VISION PROBLEMS, MY EYES STARTED GETTING WORSE"), ULCER ("ULCERS") AND HERNIA ("HERNIA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND HYSTERECTOMY (FULL); SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, HYPERSENSITIVITY, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA, ANAEMIA, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, TOOTH DISORDER, HORMONE LEVEL ABNORMAL, MIGRAINE, HEADACHE, NAUSEA, VISUAL IMPAIRMENT, WEIGHT INCREASED, ULCER AND HERNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANAEMIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HERNIA, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MENORRHAGIA, METRORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, TOOTH DISORDER, ULCER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED DATE OF INSERTION: (B)(6) 2013, (B)(6) 2013. PATIENT RECEIVED TREATMENT FOR MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORHAGIA (BLEEDING B/W PERIODS), ANEMIA UTI, VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, HAIR LOSS, DENTAL PROBLEMS, HORMONAL CHANGES, MIGRAINES, HEADACHES, NAUSEA, VISION PROBLEMS, WEIGHT GAIN, ULCERS AND HERNIA. ALLERGY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: PFS RECEIVED REPORTER INFORMATION WAS ADDED. DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORHAGIA (BLEEDING B/W PERIODS), ALLERGY, ANEMIA URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, HAIR LOSS, DENTAL PROBLEMS, HORMONAL CHANGES, MIGRAINES, HEADACHES, NAUSEA, VISION PROBLEMS, WEIGHT GAIN, ULCERS AND HERNIA ABLATION. EVENT OUTCOME ADDED MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), METRORHAGIA (BLEEDING B/W PERIODS), ANEMIA, GENITAL BLEEDING, FATIGUE, GI CONDITIONS, HAIR LOSS, DENTAL PROBLEMS, HORMONAL CHANGES, MIGRAINES, HEADACHES, NAUSEA, VISION PROBLEMS, WEIGHT GAIN, ULCERS AND HERNIA. 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.