inforMED

KIMBERLY CLARK N95 MASKS

Received Mar 1, 2021 · Event occurred Feb 10, 2021

Report MW5099713 · MDR key 11398528

Device

Generic name

Respirator, Surgical

Catalog number

46827

Product problems

  • Break
  • Product Quality Problem

Patient

Not reported

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

THE KIMBERLY CLARK N95 MASKS LOT NUMBERS REF 46827 AND REF 46727 THE STRAPS ARE DRY ROTTING, SO THEY ETHER SNAP THE STRAPS OR THEY STRETCH OUT AND DO NOT CREATE A PROPER SEAL. FDA SAFETY REPORT ID# (B)(4).