MalfunctionKHA
HALYARD FLUIDSHIELD 3 N95
Received Aug 6, 2020
Report MW5095935 · MDR key 10378719
Device
Generic name
N95 Mask, Surgical
Manufacturer
O & M Halyard, Inc.Product problems
- Device Emits Odor
Patient
35 YR
- Asthma
- Respiratory Distress
- Burning Sensation
- Asthma
- Respiratory Distress
- Burning Sensation
Narrative
Description of Event or Problem
NEWLY REPROCESSED N-95 HALYARD REGULAR DUCKBILL THAT HAS BEEN AIRED FOR A WEEK CONTINUES TO SMELL OF BURNT PLASTIC. WHEN USED, STAFF DEVELOPED ASTHMA EXACERBATION, DIFFICULTY OF BREATHING, AND CAUSING NOSE/SINUS BURN SENSATION. FDA SAFETY REPORT ID# (B)(4).