Description of Event or Problem · 1
THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORPORATION REGARDING A PRODUCT COMPLAINT ASSOCIATED WITH THE EZ BREATH ATOMIZER ON 09/25/2013. THE PATIENT REPORTED THAT THE WASHER FELL FROM THE ATOMIZER INTO HER MOUTH WHILE SHE WAS USING THE DEVICE. THE PATIENT WAS ABLE TO RETRIEVE THE COMPONENT WITHOUT REQUIRING ANY MEDICAL INTERVENTIONS. THE PT REPORTED THAT SHE HAD THREE ATOMIZERS AT THE TIME OF THE EVENT AND DID NOT RECALL THE SOURCE OF THE WASHER; THEREFORE, THE NEPHRON REPRESENTATIVE WILL SUBMIT THREE MEDICAL DEVICE REPORTS FOR THE INVESTIGATION AT THIS TIME. THE PT IS A 58 YEAR OLD FEMALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR A BRAIN ANEURYSM. SHE IS A CURRENT SMOKER AND ADDS THAT SHE DOES NOT HAVE ANY ALLERGIES TO MEDICATIONS OR ANY RESPIRATORY ILLNESSES. THE INVESTIGATED PRODUCT FOR THE ENCLOSED MEDICAL DEVICE REPORT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MANUFACTURER HEALTH AND LIFE, CO., LTD., ON 05/08/2013. THE CLASS 1 RECALL (Z-1371-2013, Z-1372-2013, Z-1372-2013) 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. (B)(4).