Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF INTESTINAL PERFORATION ('OTHER PLEASE DESCRIBE AND STATE THE LOCATION OF THE PERFORATION BOWEL') AND BLADDER PERFORATION ('PERFORATION (OTHER PLEASE DESCRIBE AND STATE THE LOCATION OF THE PERFORATION BOWEL, BLADDER (CONFIRM)') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA AND OBESITY. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET), HYDROXYZINE HYDROCHLORIDE AND IBUPROFEN. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INTESTINAL PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABDOMINAL BLEEDING (MENORRHAGIA)"), DYSGEUSIA ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: METALLIC TASTE"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), URTICARIA ("RASHES OR SKIN CONDITIONS TYPE: HIVES"), ACNE ("RASHES OR SKIN CONDITIONS TYPE: ACNE"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), TOOTH DISORDER ("DENTAL PROBLEMS"), FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PELVIC PAIN ("PELVIC PAIN FEMALE"), FATIGUE ("FATIGUE CHRONIC"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), FIBROMYALGIA ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: FIBROMYALGIA."), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), BACK PAIN ("LOWER BACK PAIN"), ARTHRALGIA ("JOINTS PAIN"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND ALLERGY TO METALS ("NICKEL ALLERGY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE INTESTINAL PERFORATION, BLADDER PERFORATION, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSGEUSIA, DEPRESSION, ANXIETY, URTICARIA, ACNE, MIGRAINE, HEADACHE, TOOTH DISORDER, FEELING ABNORMAL, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION, FIBROMYALGIA, ABDOMINAL PAIN LOWER, BACK PAIN, ARTHRALGIA, URINARY TRACT INFECTION AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ACNE, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER PERFORATION, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, HEADACHE, INTESTINAL PERFORATION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT INFECTION, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY TO BE NOTED IN ESSURE INSERTION DATE AS (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.4 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; CONFIRMING- EVENTS WHICH ARE SAME IN PFS & MR.¿ ANXIETY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-MAY-2019: PFS AND MR RECEIVED: LOT NUMBER WAS ADDED. EVENT INJURY NOS WAS UPDATED TO PERFORATION BOWEL. NEW EVENTS: METALLIC TASTE, ABDOMINAL BLEEDING (VAGINAL, MENORRHAGIA), MOOD SWINGS, DEPRESSION, ANXIETY, HIVES, ACNE, MIGRAINES, HEADACHE, DENTAL PROBLEMS, BRAIN FOG, DYSMENORRHEA (CRAMPING), DYSPAREUNIA, FATIGUE, WEIGHT GAIN, BLOATING, BLADDER PERFORATION, FIBROMYALGIA, LOWER ABDOMEN PAIN, LOWER BACK, JOINT PAIN, UTI, NICKEL ALLERGY WERE ADDED. CONCOMITANT CONDITIONS WERE ADDED. LAB DATA WAS ADDED. NEW REPORTERS WERE ADDED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.