inforMED
MalfunctionMSH

KIMBERLY-CLARK® FLUIDSHIELD¿ PFR95¿ RESPIRATOR AND SURGICAL MASK

Received Nov 16, 2021 · Event occurred Oct 9, 2021

Report 12819415 · MDR key 12819415

Device

Generic name

Respirator,surgical

Model number

46727

Product problems

  • Material Too Soft/Flexible
  • Device Fell

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

NURSING STAFF REPORT DURING DONNING KIMBERLY CLARK N95 DUCKBILL REGULAR SIZE MASK THE RUBBER BAND DIDN'T HOLD IT'S ELASTICITY CAUSING THE MASK TO FALL FROM THEIR FACE. THIS INCIDENT WAS ABLE TO BE REPEATED WITH FIVE MASKS FROM TWO DIFFERENT BOXES.