MalfunctionMSH
MEDICAL N95 MASK
Received Oct 1, 2020 · Event occurred Sep 26, 2020
Report MW5097038 · MDR key 10619639
Device
Generic name
Respirator, Surgical
Model number
N95-24/1778Product problems
- Device Markings/Labelling Problem
Patient
53 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
FALSE LABELING; MEDICAL MASK WITH EXTERIOR PACKAGING LABELED CLEARLY AS N95 - MEDICAL, BUT THE MASK IS LABELED KN95. FDA SAFETY REPORT ID# (B)(4).