D
Patient 1
PATIENT PRESCRIBED NEW EPIPEN BY (B)(6) HOSPITAL, (B)(6), ER ATTENDING PHYSICIAN ON (B)(6) AFTER ER TREATMENT FOR SEVERE ANAPHYLACTIC SHOCK DUE TO MULTIPLE YELLOW JACKET STINGS RECEIVED WHILE MOWING FARM. SEVERE REACTION REQUIRED DOUBLE DOSING AND EXTENDED STAY IN ER FOR OBSERVATION. ADVISED TO CARRY EPIPEN IN FUTURE, USE IT IMMEDIATELY IF STUNG, AND REPORT IMMEDIATELY TO ER FOR ADDITIONAL TREATMENT. PATIENT BOUGHT (B)(4) FOR EPIPEN 0.3 MG AUTO INJECTION FROM (B)(6) PHARMACY, (B)(4) ON (B)(6) 2011 AFTER LEAVING ER. DEVICE MANUFACTURED BY (B)(6), MERIDIAN MEDICAL TECHNOLOGIES, (B)(6), WHOLLY-OWNED SUBSIDIARY OF (B)(6). PATIENT STUNG AGAIN ON FARM, BUT THIS TIME BY HONEY BEE, ON (B)(6). IMMEDIATELY TRIED TO USE EPIPEN, BUT DEVICE FAILED TO FUNCTION. NEEDLE COULD NOT BE EXPOSED FROM 'ORANGE SAFETY COVER.' HIT THIGH MULTIPLE TIMES, HIT EPIPEN ON PORCELAIN SINK, HIT EPIPEN ON DASHBOARD OF CAR EN ROUTE TO ER. ARRIVED AT ER WITH THROAT SWOLLEN NEARLY CLOSED, EYES ALMOST CLOSED, DIFFICULTY BREATHING, LIFE THREATENING SITUATION. ER ATTENDING PHYSICIAN WASH ANDED EPIPEN AND ALSO COULD NOT MAKE IT FUNCTION. SAID "THIS COULD HAVE COST YOU YOUR LIFE." I WILL INVESTIGATE AND DETERMINE HOW TO REPORT. ADVISED PATIENT TO RETURN EPIPEN TO (B)(6) PHARMACY (B)(6) SO THEY COULD RETURN TO (B)(4) DISTRIBUTORS WHO COULD RETURN TO MANUFACTURER IN ORDER TO ESTABLISH CHAIN OF EVIDENCE, AND PROPER REPORTING. ISSUED NEW PRESCRIPTION FOR ALTERNATE TYPE EPIPEN (GENERIC OR ONE WITHOUT SAFETY COVER THAT KEEPS NEEDLE FROM WORKING) BUT NONE ARE AVAILABLE AT ANY OF 5 LOCAL PHARMACIES. NO OPTIONS FOR A MANDATORY LIFE SAVING DEVICE FOR THOSE WHO REACT TO HONEY BEES, WASP, YELLOW JACKET, HORNET STINGS. URGENT REVIEW OF DEVICE MALFUNCTION THAT CAUSED LIFE THREATENING CONDITION REQUESTED.