inforMED
MalfunctionMSH

KN95 MASK

Received Feb 4, 2022 · Event occurred Dec 1, 2021

Report MW5107219 · MDR key 13471930

Device

Generic name

Respirator, Surgical

Manufacturer

Hope Health Supply

Model number

KN95

Catalog number

KN95

Product problems

  • Product Quality Problem

Patient

69 YR · Male

  • Viral Infection
  • Viral Infection

Narrative

Description of Event or Problem

CONTRACTED A COVID19 INFECTION. ADVERTISER HOPE HEALTH SUPPLIES HAS SUDDENLY APPEARED LIKE A RASH ALL OVER THE INTERNET. THEY ARE MARKETING CHINESE MANUFACTURED KN95 MASKS CLAIMING THAT THESE MASKS ARE "FDA REGISTERED" AND ARE TESTED TO A HIGH STANDARD. DESPITE A TINY SMALL PRINT DISCLAIMER THAT THEY ARE NOT FOR HEALTHCARE USE, THE IMPLICATIONS MADE THROUGHOUT THE ADVERTISEMENT IS THAT THEIR KN95 MASKS ARE EFFECTIVE AGAINST COVID19 AND IT'S VARIANTS. HOPE HEALTH SUPPLIES IS CURRENTLY HEAVILY MARKETING THROUGH A POPULAR, NATIONWIDE, ON LINE NEWSLETTER CALLED (B)(6). SEVERAL OF THEIR ADVERTISEMENTS ARE MASQUERADING AS ARTICLES APPEARING AS MEDICAL JOURNALS. THESE KN95 MASKS HAVE BEEN WIDELY TESTED AND HAVE SHOWN TO BE LESS THAN 30% EFFECTIVE INSTEAD OF THE CLAIMED 95%. I HAVE CONTACTED SEVERAL INTERNET ADVERTISERS LIKE (B)(6). ALL HAVE APPARENTLY DISCONTINUED ADVERTISING FROM HOPE HEALTH SUPPLIES AS FRAUDULENT WHILE (B)(6) HAS TRIPLED THE ADVERTISING SPACE. PLEASE INVESTIGATE THESE FRAUDULENT PRODUCTS THAT CLAIM FDA REGISTRATION, IMPLYING FDA APPROVAL, AS THEIR USE IS SURELY CONTRIBUTING TO THE SPREAD OF COVID 19. THANKS, IT IS MY UNDERSTANDING THAT THESE MASKS HAVE FAILED NIOSH TESTING AS WELL AS THAT DONE BY THE FDA AND CDC. FDA SAFETY REPORT ID # (B)(4).