InjuryMSH
3M AURA 1870+ N95 MASK
Received Jun 2, 2025 · Event occurred May 26, 2025
Report MW5170974 · MDR key 22126545
Device
Product problems
- Patient Device Interaction Problem
Patient
37 YR · Female
- Hypersensitivity/Allergic reaction
- Skin Inflammation/ Irritation
- Swelling/ Edema
- Hypersensitivity/Allergic reaction
- Skin Inflammation/ Irritation
- Swelling/ Edema
Narrative
Description of Event or Problem
SERIOUS FACIAL MASK AND SWELLING FROM WEARING MASKS. NEVER HAD AN ALLERGIC REACTION TO OTHER SHIPMENTS OF THESE N95 MASKS. PUT ON MASK FROM A NEW BOX AND SHORTLY AFTER HAD ALLERGIC REACTION, REDNESS AND SWELLING OF FACE. STILL PRESENT TWO HOURS LATER. HAPPENED WITH A PREVIOUS MASK FROM THIS BOX.