inforMED
InjuryMSH

BYD. NIOSH N95 REPIRATOR

Received Oct 29, 2021 · Event occurred Oct 27, 2021

Report MW5105033 · MDR key 12727949

Device

Generic name

Respirator, Surgical

Model number

TC-84A-9221

Lot number

6200701

Product problems

  • Product Quality Problem

Patient

59 YR

  • Burning Sensation
  • Burning Sensation

Narrative

Description of Event or Problem

SEVERE BURNING IN THROAT; NIOSH RESPIRATOR. TC-84A-9221. WORE N95 RESPIRATOR THE DAY BEFORE AND WOKE UP WITH TERRIBLE BURNING IN MY THROAT, WHICH SLOWLY WENT AWAY AFTER NOT WEARING IT. CHEMICALS IN MASK SHOULD BE EVALUATED. FDA SAFETY REPORT ID # (B)(4).