Description of Event or Problem · 1
THE PT CONTACTED NEPHRON PHARMACEUTICALS CORPORATION VIA EMAIL ON (B)(6) 2014, REGARDING A PRODUCT COMPLAINT OF NO AEROSOL PRODUCTION THAT WAS REPORTED AS ASSOCIATED WITH THE MALFUNCTION OF THE EZ BREATHE ATOMIZER. THE PT REPORTED THAT THREE OF HIS ATOMIZERS FAILED TO FUNCTION; FURTHERMORE, HE ADDED THAT HE REQUIRED MEDICAL TREATMENT AT THE EMERGENCY ROOM ON DIFFERENT OCCASIONS AFTER THE ATOMIZERS FAILED TO PRODUCE A MIST TO ALLEVIATE HIS ASTHMA SYMPTOMS. DURING A FOLLOW-UP PHONE CALL ON (B)(6) 2014, THE PT REPORTED THAT HIS MOST RECENT HOSPITALIZATION OCCURRED FOUR WEEKS PRIOR TO THE DATE OF NOTIFICATION. HE REPORTED THAT HE CLEANED THE ATOMIZER USING A VINEGAR SOLUTION AS INSTRUCTED; HOWEVER, THE ATOMIZER APPEARED TO BE CLOGGED WHEN HE ATTEMPTED TO USE THE UNIT TO ALLEVIATE HIS ASTHMA EXACERBATION. AFTER THE ATOMIZER DID NOT PRODUCE A MIST, THE PT REQUIRED MEDICAL TREATMENT AT THE EMERGENCY ROOM. AT THE CONCLUSION OF THE CALL, THE PT ADDED THAT HE ALSO REQUIRED MEDICAL TREATMENT IN THE EMERGENCY ROOM WHEN THE ATOMIZER FAILED TO FUNCTION IN (B)(6) 2013. THE PT IS A (B)(6) MALE WITH A PAST MEDICAL HISTORY SIGNIFICANT FOR ASTHMA SINCE CHILDHOOD. HE IS FORMER SMOKER. THE PT REPORTED THAT HE REQUIRED MEDICAL TREATMENT IN THE EMERGENCY ROOM ON TWO DIFFERENT OCCASIONS AFTER THE ATOMIZERS FAILED TO ALLEVIATE HIS ASTHMA SYMPTOMS; THEREFORE, TWO MEDICAL DEVICE REPORTS WILL BE SUBMITTED TO THE AGENCY CONCERNING THIS PT.