Description of Event or Problem · 1
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (IGJ) ON 03-JUL-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY. IN (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PLACEMENT WAS PAINFUL"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS"), HEADACHE ("HEADACHE"), CHILLS ("CHATTERING TEETH"), ASTHENIA ("LOSS OF STRENGTH"), NEURALGIA ("NERVE PAIN"), ENTHESOPATHY ("ENTESITIS"), FATIGUE ("FATIGUE"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS"), VISUAL IMPAIRMENT ("POOR VISION"), OVULATION DISORDER ("HEAVY OVULATION") AND DYSMENORRHOEA ("MENSTRUAL PAIN"). THE PATIENT WAS TREATED WITH ESSURE REMOVAL. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, PROCEDURAL PAIN, ALOPECIA, HEADACHE, CHILLS, ASTHENIA, NEURALGIA, ENTHESOPATHY, FATIGUE, DISTURBANCE IN ATTENTION, VISUAL IMPAIRMENT, OVULATION DISORDER AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, ALOPECIA, ASTHENIA, CHILLS, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, ENTHESOPATHY, FATIGUE, HEADACHE, NEURALGIA, OVULATION DISORDER, PROCEDURAL PAIN AND VISUAL IMPAIRMENT WITH ESSURE. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR REGULATORY AUTHORITY IS NOT POSSIBLE. 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 THEIR NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.