MalfunctionMSH
MAKRITE N95 RESPIRATOR
Received Jul 7, 2020 · Event occurred Jun 30, 2020
Report MW5095407 · MDR key 10244805
Device
Product problems
- Therapeutic or Diagnostic Output Failure
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CONDUCTED FIT TESTS OF APPROX 10 MASKS OF THE MAKRITE N95 MASKS ON 7 DIFFERENT PEOPLE, INCLUDING A FULLY SEALED FILTRATION TEST AND 100% OF ALL TESTS FAILED. THE FAILURES WERE SUBSTANTIAL (NOT JUST A LITTLE). EMPLOYEE HEALTH HAVE OBSERVED QUALITATIVE FAILURES IN THEIR FIT TESTING AS WELL. UNABLE TO FIND THIS PRODUCT NUMBER AS APPROVED ON THE FDA APPROVED LIST. OBSERVED OVERALL VERY POOR QUALITY OF THE PRODUCT. FDA SAFETY REPORT ID# (B)(4).