3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK

Description of Event or Problem

A MALE WHO WAS CONDUCTING RESPIRATOR FIT TESTING AT HIS MED CTR DONNED A 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, CATALOG NUMBER 1870 ON (B)(6) 2015. WITHIN 3 MINUTES HE ALLEGED HIS FACE BURNED WHERE THE 3M SURGICAL MASK TOUCHED HIS SKIN. HE ALLEGED HIS EYES WATERED AND BURNED, HIS THROAT BECAME SCRATCHY, HE BEGAN TO SNEEZE AND HAD SHORTNESS OF BREATH. HE WENT TO THE EMERGENCY ROOM WHERE HE WAS GIVEN AN EPINEPHRINE AND INTRAVENOUS BENADRYL (DIPHENHYDRAMINE). HE WENT TO SEE AN ALLERGIST THE NEXT DAY.

Additional Manufacturer Narrative

THE DEVICE IS UNDERGOING AN EVAL BUT HAS NOT YET BEEN COMPLETED. THE EVAL OF THIS MASK HAS NOT BEEN COMPLETED BUT DEVICE HAS BEEN RETURNED FOR EVAL. CONTACT AREAS INNER WEB AND HEADBAND WERE SUBJECT TO HUMAN REPEAT INSULT PATCH TESTING (HPIRT) AND INDICATED NO CONTACT FOR SENSITIZATION BASED ON TEST SUBJECTS. USER INDICATED THEY USE A PORTACOUNT SYSTEM FOR RESPIRATOR FIT TESTING. HE DOES NOT USE THE METHOD OF EXPOSURE TO SACCHARIN.