FIRAZYR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION REQUESTED, INVESTIGATION REPORT IS PENDING.

Description of Event or Problem

PATIENT REPORTED HAVING HAD A MODERATE ABDOMINAL ATTACK FROM (B)(6) 2026-(B)(6) 2026. UNKNOWN IF ATTACK OCCURRED ON SCHEDULED PROPHYLACTIC TAKHZYRO DOSING DAY. PATIENT USED 3 DOSES OF ICATIBANT AND STATES THAT ONE OF THE PENS WAS LEAKING DURING USE. UNKNOWN DATE OF MALFUNCTION. UNKNOWN IF DEFECTIVE DEVICE IS ON HAND FOR RETURN. UNKNOWN IF PATIENT MISSED A DOSE OR EXPERIENCED ANY ADVERSE EVENTS DUE TO DEFECTIVE DEVICE. CONSENT TO CONTACT THE PATIENT'S HCP WAS NOT ASKED. ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM.