Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE"), PAIN ("BODY ACHE"), HEADACHE ("HEADACHE"), ALOPECIA ("HAIR LOSS"), VISION BLURRED ("BLURRED VISION") AND PANIC REACTION ("PANIC SYNDROME"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, DYSPAREUNIA, PAIN, HEADACHE, ALOPECIA, VISION BLURRED AND PANIC REACTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, DYSPAREUNIA, HEADACHE, PAIN, PANIC REACTION, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN AND VISION BLURRED TO BE RELATED TO ESSURE. 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 COMPLAINTS RECORDS AND OTHER NON-CONFORMANCE DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.