InjuryMSH
MASK
Received Jul 24, 2020 · Event occurred May 18, 2020
Report MW5095705 · MDR key 10325749
Device
Product problems
- Product Quality Problem
- Device Markings/Labelling Problem
Patient
Not reported
- Test Result
- Test Result
Narrative
Description of Event or Problem
THE MEDICAL MASKS FROM PACDENT, INC ARE NOT LABELED AS MEDICAL MASKS, WITH ASTM LEVEL 1-3, BUT THE ACTUAL PRODUCTS ARE OF LOW QUALITY, AND SEVERAL PATIENTS WERE TESTED POSITIVE AFTER WEARING THE MASKS. THE COMPANY CLAIMED THEIR MASKS ARE REGISTERED WITH FDA, BUT AFTER CHECKING WITH FDA , THE COMPANY INTENDED TO FALSELY USED THE REGISTRATION PRODUCT CODE MSH, WITHOUT THE FDA PREMARKET REGISTRATION. FDA SAFETY REPORT # (B)(4).