3M PARTICULATE RESPIRATOR AND SURGICAL MASK
Received May 4, 2010 · Event occurred Feb 11, 2010
Report 2110898-2010-00046 · MDR key 1678672
Device
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Erythema
- Itching Sensation
- Swelling
- Tingling
- Numbness
Narrative
Additional Manufacturer Narrative
ALTHOUGH, THERE WERE NO MEDICAL INTERVENTION NEEDED AND NO PERMANENT DAMAGE CAUSED TO THE USER, WE EVENTUALLY DECIDED TO REPORT THIS EVENT TO FDA. METHOD - WE EVALUATED THE EVENT BY REVIEWING THE HISTORY OF THE PRODUCT ON THE MARKET. RESULTS - THE USER HAS DEVELOPED ALLERGIC REACTION TO MANY PRODUCTS IN PAST TWO YEARS. CONCLUSIONS - THIS IS A RARE CASE.
Description of Event or Problem
CUSTOMER REPORTED, AN EMPLOYEE WITH A HISTORY OF RECENTLY ACQUIRED SENSITIVITIES WORE THE 1870 MASK 2 TIMES AND DEVELOPED ITCHING, REDNESS WITH SIGNIFICANT WELTS AND HER LIPS WERE NUMB AND TINGLING AFTER WEARING THE MASK FOR 20 MINUTES. REPORTEDLY SYMPTOMS RESOLVED 1-2 HOURS AFTER THE MASK WAS REMOVED, HER LIPS WERE TINGLY THE NEXT DAY AND EVENTUALLY RESOLVED. IT WAS REPORTED THERE WAS NO TREATMENT, SHE DISCONTINUED USE.