InjuryMSH
HALYARD N95 MASK
Received Sep 28, 2020 · Event occurred Sep 25, 2020
Report MW5096924 · MDR key 10600282
Device
Generic name
Respirator, Surgical
Manufacturer
BattelleProduct problems
- Patient-Device Incompatibility
Patient
Not reported
- Dyspnea
- Hypersensitivity/Allergic reaction
- Cough
- Dyspnea
- Hypersensitivity/Allergic reaction
- Cough
Narrative
Description of Event or Problem
ON (B)(6) 2020 - CONGESTION, ALLERGY ISSUES, SHORT OF BREATH, COUGH ASSOCIATED WITH USE OF BATTELLE REPROCESSED N95 MASK. PRESTIGE AMERICA. FDA SAFETY REPORT ID# (B)(4).