inforMED

PROGEAR N95 MASK

Received Sep 24, 2020

Report MW5096856 · MDR key 10586079

Device

Generic name

Respirator, Surgical

Manufacturer

Battelle

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Headache
  • Chest Tightness/Pressure
  • Cough
  • Headache
  • Chest Tightness/Pressure
  • Cough

Narrative

Description of Event or Problem

COUGH, HEADACHES, CHEST TIGHTNESS ASSOCIATED WITH BATTELLE REPROCESSED N95 MASKS. PRESTIGE AMERITECH. FDA SAFETY REPORT ID# (B)(4).