inforMED
MalfunctionMSH

MASK

Received Oct 9, 2020 · Event occurred Aug 2, 2020

Report 10655465 · MDR key 10655465

Device

Generic name

Respirator, Surgical

Model number

20040703060

Catalog number

AX-KF01

Lot number

20040703060

Product problems

  • Break

Patient

Not reported

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

MASKS WERE FOUND TO HAVE BROKEN EAR LOOPS. QTY OF 5 FROM A NEW BOX WHEN IT WAS OPENED. SENDING THE PRODUCT TO VENDOR/REP.