Description of Event or Problem · 1
THE PT CONTACTED NEPHRON PHARMACEUTICALS CORP ON (B)(6) 2013, REGARDING A PRODUCT COMPLAINT OF NO AEROSOL PRODUCTION ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER. THE PATIENT REPORTED THAT HE RECEIVED MEDICAL TREATMENT AT THE HOSPITAL, BECAUSE THE ATOMIZER FAILED TO WORK. DURING A FOLLOW-UP PHONE CALL ON (B)(6) 2013, THE PATIENT REPORTED THAT HE USED THE ATOMIZER TO HELP ALLEVIATE HIS ASTHMA SYMPTOMS; HOWEVER, HE ADDED THAT HE RECEIVED AN EPINEPHRINE INJECTION AT THE IMMEDIATE CARE DEPT OF THE HOSPITAL FOR MEDICAL TREATMENT IN NOVEMBER AFTER THE ATOMIZER FAILED TO FUNCTION. THE PT IS A (B)(6) YEAR OLD MALE WITH A PAST MEDICAL REGIMEN INCLUDES SINGULAIR (MONTELUKAST) AND UNK INHALERS. CAUSALITY IS CONSERVATIVELY ASSESSED AS POSSIBLE. HOWEVER, BASELINE CONDITION, DETAILED MEDICATION REGIMEN AND ADHERENCE TO THAT REGIMEN, EXACERBATING FACTORS AND CONCURRENT CONDITIONS WERE NOT PROVIDED AND MAY BE CONTRIBUTORY.