Description of Event or Problem · 1
(B)(4) RECEIVED A PRODUCT COMPLAINT OF A LOOSE WASHER MALFUNCTION ON (B)(4) 2014, THAT WAS REPORTED AS ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER. THE PT'S SPOUSE REPORTED THAT THE PT USED THE DEVICE TO ADMINISTER ASTHMANEFRIN (RACEPINEPHRINE INHALATION SOLUTION, 2.25%) TO ALLEVIATE HIS ASTHMA SYMPTOMS. DURING A FOLLOW-UP CALL ON (B)(6) 2014, THE INITIAL REPORTER STATED THAT SHE WAS SLEEPING AT THE TIME OF THE MALFUNCTION; HOWEVER, THE PT LATER INFORMED THE REPORTER THAT HE FELT A FOREIGN OBJECT IN HIS MOUTH WHEN SHE WOKE. THE PT BRUSHED HIS TEETH AND NOTICED THAT A SMALL WASHER WAS IN HIS MOUTH. HE WAS ABLE TO RETRIEVE THE COMPONENT WITHOUT REQUIRING ANY MEDICAL INTERVENTIONS. THERE WERE NO REPORTS OF ANY OCCURRENCES OF A SIMILAR NATURE ASSOCIATED WITH THE PT'S USE OF THE DEVICE. THE PT IS A (B)(6) YEAR OLD MALE WHO IS (B)(6). HIS PAST MEDICAL HISTORY IS SIGNIFICANT FOR ASTHMA. ADDITIONAL INFO CONCERNING THE PT'S PAST MEDICAL HISTORY, MEDICATION REGIMEN, AND ALLERGIES ARE UNK. THE REPORTER ADDED THAT THE SUSPECTED DEVICE WAS PURCHASED IN (B)(6) 2013. THE INVESTIGATED PRODUCT FOR THE ENCLOSED MEDICAL DEVICE REPORT IS LISTED AMONG THE IMPLICATED LOTS FOR A NATIONWIDE RECALL INITIATED BY THE MFR HEALTH AND LIFE, CO., LTD., ON (B)(4) 2013. THE CLASS 1 RECALL (Z-1371-2013, Z-1272-2013, Z-1373-2013) WAS INITIATED AFTER (B)(4), 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).