inforMED
InjuryMSH

PROGEAR REPROCESSED N95 MASKS

Received Sep 24, 2020 · Event occurred Aug 31, 2020

Report MW5096860 · MDR key 10586115

Device

Generic name

Respirator, Surgical

Manufacturer

Battelle

Product problems

  • Patient-Device Incompatibility

Patient

Not reported

  • Headache
  • Sneezing
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Headache
  • Sneezing
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

SNEEZING, HEADACHES, AND NASAL DRIP ASSOCIATED WITH BATTELLE REPROCESSED N95 MASKS; PRESTIGE AMERITECH. FDA SAFETY REPORT ID# (B)(4).