MalfunctionMSH
N95 RESPIRATOR MASK
Received Jan 10, 2022 · Event occurred Jan 6, 2022
Report MW5106573 · MDR key 13225170
Device
Generic name
Respirator, Surgical
Manufacturer
Demetech Corp.Model number
P/N:DT -N95-FHLot number
A365-21
Product problems
- Detachment of Device or Device Component
Patient
70 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
I PURCHASED SOME DEMETECH N95 RESPIRATOR MASKS FROM PROJECT N95. I TRIED ONE ON TODAY AND THE BOTTOM STRAP DETACHED FROM THE MASKS. I TRIED 2 OTHERS ON AND THE SAME THING HAPPENED. NIOSH TC-84A-9251, LOT #A365-21, EXPIRATION DATE: 01/2026. FDA SAFETY REPORT ID# (B)(4).