InjuryMSH
BYD N95 NIOSH PARTICULATE RESPIRATOR
Received Feb 4, 2022 · Event occurred Feb 1, 2022
Report MW5107234 · MDR key 13472530
Device
Generic name
Respirator, Surgical
Manufacturer
Byd Precision Manufacture Co., Ltd.Model number
DE2322Catalog number
NIOSH N95 - TC-84A-9221
Product problems
- Patient Device Interaction Problem
Patient
20 YR · Female
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Description of Event or Problem
SERVE ALLERGIC REACTION TO THE BYD-N95 NIOSH PARTICULATE RESPIRATOR, USA CDC + FDA REGISTERED AND APPROVED FOR MEDICAL USE WITHIN THE USA. SOLD TO HOSPITALS. NIOSH TC-84A-9221 PURCHASED FROM (B)(4) AT (B)(4). FDA SAFETY REPORT ID # (B)(4).