Description of Event or Problem · 1
THE CUSTOMER'S SPOUSE REPORTED A PRODUCT COMPLAINT ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER ON (B)(6) 2013, WHILE NEPHRON WAS VERIFYING THE RECEIPT OF THE RECALL NOTIFICATION. PRIOR TO RECEIVING NEPHRON'S RECALL NOTIFICATION, THE INITIAL REPORTER STATED THAT HIS HUSBAND BECAME BLUE IN THE FACE THIRTY MINUTES AFTER USING THE EZ BREATHE ATOMIZER. THE PT WENT TO THE HOSPITAL AND RECEIVED MEDICAL TREATMENT OVER THE COURSE OF TWO AND A HALF DAYS. IN ADDITION, THE COMPLAINANT REPORTED THAT AN UNIDENTIFIED SCAN DISCOVERED A CIRCULAR PIECE LODGED IN THE PT'S THROAT THAT REQUIRED A MEDICAL INTERVENTION TO REMOVE THE COMPONENT. THE PT'S PHARMACIST THEN NOTIFIED THE PT OF THE RECALL AND ADVISED THAT THE PT LOOK FOR THE WASHER IN HIS ATOMIZER. IT WAS DETERMINED THAT THE WASHER WAS MISSING AT THAT TIME. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CUSTOMER VIA TELEPHONE AND BY MAIL UNSUCCESSFULLY. 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).