MalfunctionMSH
KN95
Received Jul 9, 2020 · Event occurred Jul 7, 2020
Report MW5095456 · MDR key 10257242
Device
Generic name
Respirator, Surgical
Manufacturer
UnkProduct problems
- Break
- Failure of Device to Self-Test
Patient
34 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PURCHASED A KN95 MASK FROM A (B)(6) VENDING MACHINE AT AN AIRPORT. I BELIEVE THESE ARE UNQUALIFIED AS THE STRAP BROKE AND I OPENED IT UP, AND IT FAILED ALL TESTING INSPECTIONS. I UNDERSTAND THAT THE FDA HAS A SPECIFIC EUA LIST FOR ALLOWABLE ACCEPTABLE KN95 MASKS AND THESE ARE NOT ON IT, THEY SHOULD BE REMOVED IMMEDIATELY. ESPECIALLY SINCE I (B)(6) AND SAW THAT (B)(6) HAS THESE VENDING MACHINES ACROSS THE NATION; (B)(6). (B)(6). FDA SAFETY REPORT ID # (B)(4).