MalfunctionMSH
AX-KN95
Received Apr 19, 2022
Report MW5109197 · MDR key 14162262
Device
Generic name
Respirator, Surgical
Manufacturer
Dongguan Aoxing Audio Visual Equipment Co.,ltd.Product problems
- Device Markings/Labelling Problem
Patient
33 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PURCHASED "KN95" MASKS FROM (B)(6). THE MASKS ARE PRODUCED BY A COMPANY CALLED (B)(6). THE MASKS LACK ANY OFFICIAL MARKINGS OR DOCUMENTATION ABOUT THEIR COMPOSITION. FDA SAFETY REPORT IDS# (B)(4).