inforMED
MalfunctionMSH

KN95 MASK BONCARE

Received Nov 8, 2021

Report MW5105208 · MDR key 12780536

Device

Generic name

Respirator, Surgical

Product problems

  • Therapeutic or Diagnostic Output Failure

Patient

22 YR · Male

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

ORDERED "KN95" MASKS OFF OF (B)(6) AND THEY ARE FAKE, I TOLD (B)(6) AND THEY REFUSE TO DO ANYTHING. PRODUCT IS CLEARLY ADVERTISED AS A KN95 NOWHERE CLOSE TO AS EFFECTIVE. FDA SAFETY REPORT ID# (B)(4).