3M AURA HEALTHCARE PARTICULATE RESPIRATOR N95 MASK
Received Jan 2, 2026 · Event occurred Dec 1, 2024
Report MW5181601 · MDR key 23945007
Device
Patient
Female
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Hot Flashes/Flushes
- Swelling/ Edema
- Nasal congestion
Narrative
Description of Event or Problem
THIS ISSUE HAPPENED ON MULTIPLE DATES, MULTIPLE YEARS. HOSPITAL NURSE WEARING 3M 1870+ RESPIRATOR HAD FLUSHED/HOT FACIAL SKIN, TIGHTENING OF THROAT, SWELLING OF TONGUE AND/OR LIPS. THIS HAPPENED ON MULTIPLE OCCASIONS WHEN THIS MASK WAS THE ONLY STYLE OF RESPIRATOR AVAILABLE FOR IMMEDIATE USE. RN (REGISTERED NURSE) NOTICES ADVERSE REACTION UPON DONNING MASK, WHICH WORSENS WITH LENGTH OF USE. IF REQUIRED MORE THAN A FEW HOURS OUT OF A DAY, RN WILL NEED NEBULIZED ALBUTEROL AND ANTIHISTAMINES. WORN FOR MORE THAN A FEW HOURS OUT OF THE DAY, RN ALSO EXPERIENCES NASAL AND SINUS CONGESTION AND ITCHY EYES. RN HAS IDENTIFIED STRONG CHEMICAL/RUBBERY SMELL COMING FROM RED ELASTIC BANDS AS SOURCE OF IRRITANT. RN HAS SEASONAL ALLERGIES WITH HYPERSENSITIVITIES, REACTIVE AIRWAY, ASTHMA; HISTORY OF SMOKING- QUIT 20 YEARS AGO, OBESITY.