KN95 MASK (KIDS)
Received Feb 23, 2022 · Event occurred Feb 21, 2022
Report MW5107646 · MDR key 13591779
Device
Product problems
- Product Quality Problem
- Device Markings/Labelling Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
I ORDERED MASKS FROM THE COMPANY "(B)(6)" THAT WERE ADVERTISED AS KN95 AND AS MEETING KN95 STANDARDS. THE PACKAGE HAD THE "(B)(4)" IMPLEMENTATION STANDARD PRINTED ON IT. HOWEVER, THE INDIVIDUAL MASKS HAD NO SUCH STAMP ON THEM. I CONTACTED THE COMPANY AND THEY TOLD ME THAT THE NEW MACHINES THEY HAVE ARE STILL WAITING FOR THE "KN95" MOLDS AND THAT THE QUALITY IS THE SAME. HOWEVER I DO NOT FEEL THAT THE COMPANY SHOULD BE ADVERTISING THE MASKS AS KN95 AND PUTTING THEM IN PACKAGES THAT HAVE THESE IMPLEMENTATION STANDARDS ON THEM AND THEN THE MASK ITSELF IS QUESTIONABLE. I KNOW THAT LEGITIMATE KN95 MASKS SHOULD HAVE THE STAMP AND IMPLEMENTATION STANDARD ON THEM. I FEEL THIS COMPANY HAS A QUALITY CONTROL ISSUE OR IS FRAUDULENTLY SENDING OUT MASKS THAT AREN'T ACTUALLY KN95S. FDA SAFETY REPORT ID # (B)(4).