3M¿ AURA¿
Received Jul 15, 2022 · Event occurred Jun 28, 2022
Report 2110898-2022-00048 · MDR key 15032240
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Dyspnea
- Hot Flashes/Flushes
- Dyspnea
- Hot Flashes/Flushes
Narrative
Description of Event or Problem
A NURSE REPORTED FLUSHING, SHORT OF BREATH AND THROAT TIGHTENING AFTER USE OF 3M¿ AURA¿ HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 1870+, N95. UNKNOWN HOW LONG THE NURSE WAS WEARING THE MASK PRIOR TO SYMPTOMS. THE NURSE WAS SEEN IN THE EMERGENCY DEPARTMENT AND AN ANTIHISTAMINE WAS GIVEN. SYMPTOMS RESOLVED AND NO FURTHER TREATMENT WAS REQUIRED.
Additional Manufacturer Narrative
3M¿ TAKES VERY SERIOUSLY THE SAFETY OF OUR PRODUCTS AND WE REVIEW THE POSSIBLE CAUSES OF ALL COMPLAINTS. SINCE THE INTENDED USE OF THIS PRODUCT INCLUDES SKIN CONTACT, THE MATERIALS USED IN THE RESPIRATOR HAVE BEEN EVALUATED BY TOXICOLOGISTS IN THE 3M MEDICAL DEPARTMENT PAYING PARTICULAR ATTENTION TO BASE CHEMICALS AND RAW MATERIALS WHICH MIGHT POSE RISK FOR DERMAL IRRITATION, ALLERGY, OR TOXICITY. BASED ON THESE REVIEWS, NO RISK FOR ADVERSE HEALTH EFFECTS IS EXPECTED WHEN THE RESPIRATOR IS USED AS INTENDED AND FOLLOWING INSTRUCTIONS FOR USE. 3M WILL CONTINUE TO MONITOR. ADDITIONALLY, THE MANUFACTURING LOCATIONS HAVE PROCESSES FOR CONTROLLING CONTAMINATION DURING THE MANUFACTURING OF THE PRODUCT. THE AREAS WHERE MEDICAL DEVICE RESPIRATOR IS MANUFACTURED HAVE SPECIFIC APPROVED PROCESSING AIDES WHICH CAN BE USED. FOR THOSE AIDES WHICH COULD COME INTO CONTACT WITH THE PRODUCT, TOXICOLOGICAL REVIEWS HAVE BEEN PERFORMED. IN ADDITION, THE MANUFACTURING LINE IS CLEANED WITH APPROVED SUPPLIES AS PART OF THE CONTAMINATION CONTROL PROCEDURES.