Description of Event or Problem · 1
THE PT CONTACTED NEPHRON PHARMACEUTICALS CORPORATION ON (B)(6) 2013, REGARDING A REPORTABLE PRODUCT COMPLAINT OF NO AEROSOL PRODUCTION ASSOCIATED WITH THE EZ BREATHE ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST DESPITE CLEANING THE UNIT ACCORDING TO THE PRODUCT'S INSTRUCTIONS. DURING A F/U PHONE CALL ON (B)(6) 2013, THE PT ADDED THAT HE EXPERIENCED AN ASTHMA ATTACK WHEN THE ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST; HOWEVER, HE REPORTED THAT HE USED A FRIEND'S INHALER TO ALLEVIATE THE SYMPTOMS OF HIS ASTHMA EXACERBATION. THE PT IS A 46 YR OLD MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA (ALL HIS LIFE). HE REPORTED THAT HE IS A FORMER SMOKER AND IS NOT AWARE OF ANY ALLERGIES TO MEDICATIONS. THE INVESTIGATED PRODUCT FOR THE ENCLOSED MEDICAL DEVICE REPORT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MFR HEALTH & LIFE, CO., LTD., ON MAY 8, 2013. THE CLASS 1 RECALL (Z-1371-2013, Z-1372-2013, Z-1373-2013) WAS INITIATED AFTER NEPHRON PHARMACEUTICALS CORPORATION, THE IMPORTER, BECAME AWARE OF AN INCREASING NUMBER OF COMPLAINTS ASSOCIATED WITH THE POSSIBILITY OF A QUARTER-INCH WASHER BECOMING DISLODGED FROM THE EZ BREATH ATOMIZER. THE IMPACTED ATOMIZER SERIAL NUMBER RANGES ARE: (B)(4). BASELINE RESPIRATORY STATUS, CONCOMITANT MEDICATIONS AND THE CLINICAL COURSE OF ASTHMA ATTACK WERE NOT PROVIDED. CAUSALITY IS CONSERVATIVELY ASSESSED AS POSSIBLE, DUE TO LACK OF ADMINISTRATION.