3M¿ AURA¿
Received Jan 14, 2022 · Event occurred Jan 3, 2022
Report 2110898-2022-00005 · MDR key 13261448
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Anaphylactic Shock
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Anaphylactic Shock
- Hypersensitivity/Allergic reaction
- Itching Sensation
Narrative
Additional Manufacturer Narrative
PATIENT INFORMATION: NOT AVAILABLE. NO SAMPLE AVAILABLE. 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.
Description of Event or Problem
AN OPERATING ROOM NURSE REPORTED TINGLING, ITCHING AND SWELLING OF AIRWAY WITH DIFFICULTY BREATHING AFTER APPLYING 3M¿ AURA¿ PARTICULATE RESPIRATOR 9205+, N95. SYMPTOMS OCCURRED SHORTLY AFTER APPLYING THE MASK AND STOPPED ALMOST IMMEDIATELY AFTER REMOVING THE MASK. NO MEDICAL INTERVENTIONS WERE REQUIRED, AND ALL SYMPTOMS RESOLVED.