inforMED
MalfunctionMSH

KN95 MASKS

Received Jun 4, 2020 · Event occurred Jun 2, 2020

Report MW5094846 · MDR key 10122899

Device

Generic name

Respirator, Surgical

Model number

KN95

Catalog number

6 973138 610028

Product problems

  • Packaging Problem

Patient

56 YR

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

Narrative

Description of Event or Problem

I HAVE RECEIVED AN ORDER FROM (B)(6) AND AM APPALLED TO FIND THE KN95 MASKS WERE SHIPPED IN AN OPEN BOX!!! THEY ARE MADE BY (B)(6) FROM HUBEI PROVINCE! THE BLUE REGULAR MASKS WERE ALSO SHIPPED IN AN OPEN MANILA ENVELOPE! THE KN95 MASKS ARE NOT FDA APPROVED AND WERE SHIPPED IN THE SAME PACKAGE AS THE OTHER MASKS (OPEN ENVELOPE) AND THE OXYGEN MASK/TUBING. BECAUSE OF THEIR POOR PROCEDURES AND OBVIOUSLY FALSE ADVERTISING, I NOW HAVE TO WORRY THAT I WILL BE INFECTED BECAUSE OF THIS SHIPMENT! FDA SAFETY REPORT ID #: (B)(4).