Description of Event or Problem · 1
THE PT CONTACTED NEPHRON PHARMACEUTICALS CORP REGARDING A PRODUCT COMPLAINT OF LOOSE WASHER ON (B)(6) 2013, ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER. THE PT REPORTED THAT A SILVER CIRCULAR RING FELL FROM THE MEDICATION CUP INTO HIS MOUTH WHILE USING THE PRODUCT. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO REACH THE CUSTOMER VIA TELEPHONE; HOWEVER, ADD'L F/U ATTEMPTS WILL BE CONDUCTED. IN ADDITION, AN INVESTIGATION NOTIFICATION LETTER WILL BE MAILED TO THE PT VIA (B)(4) THAT REQUIRES CONFIRMATION OF THE DELIVERY. MEDICAL REVIEW: AN ADVERSE EVENT WAS NOT REPORTED IN ASSOCIATION WITH THIS PRODUCT COMPLAINT. 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 05/08/2013. THE CLASS 1 RECALL (Z-1371-2013, Z-1372-2013, Z-1373-2013) WAS INITIATED AFTER NEPHRON PHARMACEUTICALS CORP, 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).