Description of Event or Problem · 1
THE CUSTOMER'S SPOUSE SPOUSE CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATHE ATOMIZER ON (B)(6) 2013. THE INITIAL REPORTER STATED THAT THE ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST WHILE HER HUSBAND WAS EXPERIENCING AN ASTHMA ATTACK. HER HUSBAND WENT TO THE EMERGENCY DEPARTMENT AT THE HOSPITAL AND REQUIRED NEBULIZER TREATMENTS TO ALLEVIATE HIS ASTHMA SYMPTOMS. THE PT IS A (B)(6) Y/O MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA. HE IS A NONSMOKER AND REPORTS ALLERGIES TO PENICILLIN. 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 BREATHE ATOMIZER. THE IMPACTED ATOMIZER SERIAL NUMBER RANGES ARE: (B)(4).