Description of Event or Problem · 1
THE PT CONTACTED (B)(4) CORPORATION ON (B)(6), 2013, REGARDING A REPORTABLE PRODUCT COMPLAINT OF LOOSE WASHER ASSOCIATED WITH THE EZ BREATHE ATOMIZER, THE PT REPORTED THAT SHE HAD THREE ATOMIZERS ASSOCIATED WITH THE COMPANY'S CLASS 1 RECALL THAT SHE PURCHASED WHEN THE ASTHMANEFRIN STARTER KIT WAS FIRST INTRODUCED. IN ADDITION, A WASHER FELL FROM ONE OF THE UNITS INTO HER THROAT; HOWEVER, SHE DOES NOT RECALL WHICH ATOMIZER WAS THE SOURCE OF HER COMPLAINT. DURING A F/U PHONE CALL ON (B)(6), 2013, SHE REPORTED THAT THE WASHER EJECTED FROM THE ATOMIZER INTO HER THROAT DURING THE INITIAL USE; HOWEVER, SHE ADDED THAT SHE WAS ABLE TO COUGH THE WASHER UP W/O REQUIRING ANY MEDICAL INTERVENTIONS. THE PT IS A (B)(6) FEMALE WHO REPORTED THAT HER PAST MEDICAL HISTORY IS SIGNIFICANT FOR ASTHMA (B)(6). AS STATED PREVIOUSLY, THE ATOMIZER UNDER INVESTIGATION WAS NOT IDENTIFIED; THEREFORE, ALL THREE UNITS WILL BE REPORTED TO THE AGENCY AS ASSOCIATED WITH THE 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 MAY 8, 2013. THE CLASS 1 RECALL (Z-1371-2013, Z-1372-2013, Z-1373-2013) WAS INITIATED AFTER (B)(4) 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 BREATH ATOMIZER. THE IMPACTED ATOMIZER SERIAL NUMBER RANGES ARE: (B)(4). NO SEQUELAE WERE REPORTED SECONDARY TO THIS PRODUCT COMPLAINT.