AEROCHAMBER PLUS FLOW-VU BLUE PLASTIC MOUTHPIECE

Description of Event or Problem

REPORTER CALLING, STATING SHE FEELS SHE EXPERIENCED AN ALLERGIC REACTION TO THE BLUE DYE IN THE MOUTHPIECE OF HER AEROCHAMBER PLUS FLOW-VU DEVICE. SHE STATES HER ALLERGIST PUT HER ON INHALER MEDICATION "YEARS AGO". SHE STATES THAT AFTER USING THIS DEVICE, THE INSIDE OF HER LIPS "BURN" WHEREVER THEY CONTACT THE SURFACE OF THE MOUTHPIECE PART. SHE FEARS SHE IS HAVING AN ALLERGIC REACTION TO THE BLUE DYE IS USED IN THE PLASTIC MOUTHPIECE, AND THAT THIS REACTION COULD EXACERBATE HER UNDERLYING ASTHMA. SHE STATES SHE HAS CONTACTED THE MANUFACTURER TO INQUIRE ABOUT THE MATERIAL THE BLUE DYE IS COMPOSED OF, BUT HAS YET TO RECEIVE A DEFINITIVE ANSWER. REPORTER STATES THIS FIRST OCCURRED "TWENTY YEARS AGO" AND CONTINUES TO OCCUR WHENEVER SHE HAS TO USE THIS DEVICE. "UPC: 3-04563154676; RMC 15905; REV. 08-2012. (B)(6)."