MalfunctionMSH
FITUSA MANUFACTURING EARLOOP STYLE BASIC FACEMASK
Received May 12, 2020 · Event occurred May 6, 2020
Report MW5094457 · MDR key 10051270
Product problems
- Product Quality Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
FITUSA MANUFACTURING IS SELLING POORLY-MADE FACE MASKS AND ADVERTISING THAT THE MASKS HAVE AN FDA CLASSIFICATION. "CLASSIFICATION REGULATION: 21 CFR 868.5450; DEVICE TYPE: HUMIDIFIER, RESPIRATORY MASK; PRODUCT CODE: OBN." THE INFORMATION IS FALSE. THE MASKS ARE SINGLE LAYER, HIGHLY-PERMEABLE MASKS THAT SERVE LITTLE PURPOSE TO PREVENT THE SPREAD OF COVID-19. FDA SAFETY REPORT ID# (B)(4).