inforMED
MalfunctionMSH

POWECOM KN95 FACE MASK

Received Jul 7, 2020 · Event occurred Jul 1, 2020

Report MW5095395 · MDR key 10244588

Device

Generic name

Respirator, Surgical

Model number

KN95

Product problems

  • Fluid/Blood Leak

Patient

39 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

HI, I WANTED TO REPORT A PRODUCT THAT IS CURRENTLY ON THE FDA EUA APPENDIX A LIST FOR AUTHORIZED RESPIRATORS. IT IS THE KN95 MASKS FROM GUANGZHOU POWECOM LABOR INDUSTRIES (WWW.POWECOM.COM) THE POWECOM SITE NOW HAS AN AUTHORIZED US DISTRIBUTOR (B)(4) WHO IS SELLING THEIR MASKS WITH THEIR ANTI-FAKE STICKERS. A FEW PEOPLE INCLUDING MYSELF ON AN ONLINE FORM HAVE BEEN TESTING THESE LEGIT SOURCED MASKS USING THE SIMPLE WATER TEST AND THE MASKS BEAD/LEAK WATER ALMOST IMMEDIATELY. I AM RECOMMENDING THE FDA/CDC TAKE A LOOK AT THIS SUPPLIER AGAIN AND CONSIDER REMOVING THEM FROM THE EUA APPENDIX A LIST MUCH LIKE (B)(4) HAS DONE RECENTLY. THE QUALITY SEEMS INFERIOR TO WHAT THEY ARE SELLING NOW OR WHAT WAS TESTED BY THE CDC IN PREVIOUS MONTHS. THANK YOU FOR EVERYTHING YOU ARE DOING FOR THE PUBLIC. FDA SAFETY REPORT ID# (B)(4).