Description of Event or Problem · 1
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), REFERENCE NUMBER: (B)(4)) ON 10-DEC-2018. THE MOST RECENT INFORMATION WAS RECEIVED ON 20-DEC-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEADACHE ("HEADACHES") AND DEPRESSION IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945069) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2012, THE PATIENT EXPERIENCED HEADACHE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIZZINESS, ALOPECIA ("HAIR LOSS"), MUSCULOSKELETAL PAIN ("MUSCLE AND JOINT PAIN"), VISUAL IMPAIRMENT ("DECREASED VISION") AND TACHYCARDIA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2017, THE PATIENT EXPERIENCED DEPRESSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). AT THE TIME OF THE REPORT, THE HEADACHE, DEPRESSION, DIZZINESS, ALOPECIA, MUSCULOSKELETAL PAIN, VISUAL IMPAIRMENT AND TACHYCARDIA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ALOPECIA, DEPRESSION, DIZZINESS, HEADACHE, MUSCULOSKELETAL PAIN, TACHYCARDIA AND VISUAL IMPAIRMENT WITH ESSURE. THE REPORTER COMMENTED: SHE WAS ON LONG-TERM SICK LEAVE DUE TO DEPRESSION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE (B)(6) KGS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-DEC-2018: QUALITY-SAFETY EVALUATION OF PTC. 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.