MalfunctionMSH
ANTI BACTERIA, POLLUTION AND DUST MASK N95
Received Mar 13, 2020 · Event occurred Mar 8, 2020
Report MW5093768 · MDR key 9834913
Device
Generic name
Respirator, Surgical
Manufacturer
UnkProduct problems
- Product Quality Problem
Patient
71 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ORDERED AND RECEIVED A SO CALLED N 95 MASK FROM COMPANY STABILITY PRO - (B)(4) BASED. THE PRODUCT CAME IN A CELLOPHANE BAG WITHOUT ANY LABEL, PRECAUTIONS, INSTRUCTIONS FOR USE OR OTHER INFO REGARDING PRODUCT OR MATERIALS ETC. MASK IS CLEARLY A COUNTERFEIT. MADE OF NEOPRENE, FUMES ENOUGH TO CAUSE COUGH. ONE PAPER MASK LINER AND SIDE FILTERS HOLDERS WITHOUT FILTERS. ADVERTISED PRODUCT SAID WOULD COME WITH FILTERS. COST WAS (B)(6). THEY DO NOT RESPOND TO EMAIL. NO TESTING. WAS NOT MADE AVAILABLE. FDA SAFETY REPORT ID# (B)(4).