inforMED
MalfunctionMSH

N95 MASK

Received Sep 9, 2022 · Event occurred Sep 5, 2022

Report MW5111967 · MDR key 15401775

Device

Generic name

Respirator, Surgical

Model number

TC-84A-9276

Product problems

  • Product Quality Problem
  • Inadequacy of Device Shape and/or Size
  • Structural Problem

Patient

45 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

I BOUGHT A 20 PACK OF MASKS FROM AMAZON, MADE BY YQ YICHITA. THEY CLAIM TO BE NIOSH APPROVED, SO I THOUGHT I WOULD TRY THEM. THE MASKS WERE OF VERY POOR QUALITY, I DO NOT TRUST THAT THEY ARE ACTUALLY LIVING UP TO THE NIOSH STANDARD. THE MASKS WERE WRINKLED, THEY DID NOT HAVE A CONSISTENT SHAPE, AND THEY DO NOT FIT THE FACE THE WAY THEY SHOULD. THE WAY THEY ATTACHED THE ELASTIC BANDS SEEMED VERY FLIMSY, LIKE IT COULD SNAP VERY EASILY. THE PLACE WHERE THE ELASTIC WAS ATTACHED WAS ACTUALLY SEE THROUGH. MY HUSBAND ONLY HAS ONE LUNG, SO IT HAS BEEN VERY IMPORTANT THROUGHOUT THE PANDEMIC FOR US TO FIND HIGH QUALITY MASKS THAT FIT THE STANDARDS AND LIVE UP TO THE CLAIMS MADE BY THE COMPANY THAT MAKES THEM. FDA SAFETY REPORT ID # (B)(4).