inforMED
MalfunctionMSH

TRULY CALM

Received Apr 4, 2022 · Event occurred Feb 7, 2022

Report 13994717 · MDR key 13994717

Device

Generic name

Respirator, Surgical

Model number

EARLOOP KN95

Lot number

202005

Product problems

  • Material Split, Cut or Torn

Patient

Unknown

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

Narrative

Description of Event or Problem

KN95 MASKS ARE SPLITTING ON THE CHIN PIECE. WE HAVE FOUND THAT AT LEAST 20 MASKS HAVE SPLIT.