MalfunctionMSH
N95 RESPIRATOR MASKS
Received Jan 15, 2021
Report MW5098852 · MDR key 11193958
Device
Product problems
- Defective Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
N95 RESPIRATOR MASKS LOT # B20020 WAS REPORTED TO THE STOREROOM AND ASKED TO BE REPLACED AS THE MASKS ARE ILL FITTING, ELASTIC TOO LOOSE CAUSING IMPROPER FIT AND THEREFORE PLACING STAFF AT INCREASED RISK AT CONTRACTING COVID. FDA SAFETY REPORT ID# (B)(4).