3M¿ PARTICULATE RESPIRATOR

Additional Manufacturer Narrative

PRODUCT CODE MSH IS BEING USED AS A PLACEHOLDER FOR THIS DEVICE. DURING THE PUBLIC HEALTH EMERGENCY OF THE COVID-19 PANDEMIC, STANDARD N95 "INDUSTRIAL" RESPIRATORS MAY BE USED BY HEALTHCARE PROFESSIONALS ACCORDING TO THE U.S. FDA'S EMERGENCY USE AUTHORIZATION (EUA). 3M¿ PARTICULATE RESPIRATOR 8210 IS NOT CLEARED BY THE U.S. FDA AS A SURGICAL MASK; THEREFORE, THERE IS NOT A UDI, PRODUCT CODE OR 510K NUMBER FOR THIS DEVICE. 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

A PHYSICIAN ALLEGED CHEST PAIN, ALLERGIC BRONCHITIS, PAIN FROM THE METAL NOSE CLIP AND A SMALL RASH ON THE EYELID AFTER USE OF 3M¿ PARTICULATE RESPIRATOR 8210, N95. SYMPTOMS STARTED AT THE END OF THE DAY AND THE FOLLOWING DAY. MEDICAL INTERVENTIONS WERE INDICATED FOR CHEST PAIN, ALTHOUGH NOT IDENTIFIED. (B)(6), SHE REPORTED THE START OF HER CHEST PAIN. SIX DAYS LATER SHE WAS TESTED FOR COVID-19 AND RESULTS WERE NEGATIVE. THE FOLLOWING DAY SHE REPORTED AN INCREASE IN PAIN WHILE EXERCISING AND WAS SEEN IN THE EMERGENCY ROOM. NO HEART ISSUES WERE FOUND. CURRENTLY SYMPTOMS HAVE DECREASED ALTHOUGH DURING AND AFTER EXERCISE SHE REPORTS CHEST TIGHTNESS AND PAIN. MEDICAL HISTORY INCLUDES MULTIPLE CONTACT ALLERGENS. NO FURTHER INFORMATION.

Additional Manufacturer Narrative

PRODUCT CODE MSH IS BEING USED AS A PLACEHOLDER FOR THIS DEVICE. DURING THE PUBLIC HEALTH EMERGENCY OF THE COVID-19 PANDEMIC, STANDARD N95 "INDUSTRIAL" RESPIRATORS MAY BE USED BY HEALTHCARE PROFESSIONALS ACCORDING TO THE U.S. FDA'S EMERGENCY USE AUTHORIZATION (EUA). 3M¿ PARTICULATE RESPIRATOR 8210 IS NOT CLEARED BY THE U.S. FDA AS A SURGICAL MASK; THEREFORE, THERE IS NOT A UDI, PRODUCT CODE OR 510K NUMBER FOR THIS DEVICE. 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

A PHYSICIAN ALLEGED CHEST PAIN, ALLERGIC BRONCHITIS, PAIN FROM THE METAL NOSE CLIP AND A SMALL RASH ON THE EYELID AFTER USE OF 3M¿ PARTICULATE RESPIRATOR 8210, N95. SYMPTOMS STARTED AT THE END OF THE DAY AND THE FOLLOWING DAY. MEDICAL INTERVENTIONS WERE INDICATED FOR CHEST PAIN, ALTHOUGH NOT IDENTIFIED. (B)(6), SHE REPORTED THE START OF HER CHEST PAIN. SIX DAYS LATER SHE WAS TESTED FOR COVID-19 AND RESULTS WERE NEGATIVE. THE FOLLOWING DAY SHE REPORTED AN INCREASE IN PAIN WHILE EXERCISING AND WAS SEEN IN THE EMERGENCY ROOM. NO HEART ISSUES WERE FOUND. CURRENTLY SYMPTOMS HAVE DECREASED ALTHOUGH DURING AND AFTER EXERCISE SHE REPORTS CHEST TIGHTNESS AND PAIN. MEDICAL HISTORY INCLUDES MULTIPLE CONTACT ALLERGENS. NO FURTHER INFORMATION.