REGARD

Additional Manufacturer Narrative

THE FACILITY REPORTED THAT THEIR STAFF HAD NOT BEEN FIT TESTED FOR THE MASKS PRIOR TO USE AS REQUIRED. THIS IS LIKELY A CONTRIBUTING FACTOR TO THE CONCERNS RAISED BY THE USERS. ADDITIONALLY, ROI PROVIDES DONNING AND DOFFING INSTRUCTIONS TO AIDE IN PROPER USE OF THE MASKS. THE INSTRUCTIONS WERE NOT USED OR FOLLOWED PRIOR TO USE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT TEAM MEMBERS AND PROVIDERS ARE CONCERNED WITH THE PRODUCT QUALITY STATING THAT IT IS FLIMSY AND DOES NOT SEAL TO THEIR FACE APPROPRIATELY DUE TO STRAP DESIGN. STAFF ALSO RAISED CONCERN THAT THEY WERE NOT FIT TESTED FOR THE MASK PRIOR TO DONNING AND USE.