Description of Event or Problem · 1
THIS CASE WAS REPORTED BY A CONSUMER, VIA (B)(4) , AND DESCRIBED THE OCCURRENCE OF ASPIRATION OF LIQUID IN A MALE PT WHO REC'D ORAL MOISTURIZERS (BIOTENE ORAL BALANCE GEL (2013 FORMULATION)) GEL FOR DRY TONGUE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED ORAL MOISTURIZERS (DENTAL). AT AN UNK TIME AFTER STARTING ORAL MOISTURIZERS, THE PT EXPERIENCED ASPIRATION OF LIQUID, COUGH, WAKING UP IN PAIN AND LACK OF EFFECT. THE ORIGINAL CONTACT WITH THE PT DID NOT REVEAL ANY ADVERSE EVENTS. F/U CONTACT WAS REC'D BY THE PT VIA (B)(4) ON (B)(4) 2014. THE PT STATED, "THE NEW FORMULA DOES NOT WORK. I USE THE GEL AT NIGHT. I PUT A SMALL AMOUNT ON MY TONGUE JUST BEFORE I FALL ASLEEP. THE NEW FORMULA TURNS IMMEDIATELY TO LIQUID. WHEN I LIE DOWN, THE GEL BECOMES A LIQUID AND RUNS DOWN THE BACK OF MY TONGUE! I WAKE UP COUGHING, HAVING ASPIRATED THE LIQUID. OR, I WAKE IN AN HR FROM THE PAIN OF MY DRY TONGUE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY (B)(4). AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. AE F/U INFO WAS REC'D (B)(4) 2014. THE PT REPORTED THAT HE HAS CONTACTED HIS PHYSICIAN ABOUT THE EVENTS. HE STATED THAT HE SLEEPS ON HIS BACK, AND THE NEW BIOTENE ORAL BALANCE GEL GOES INTO HIS LUNGS AND HE WAKES UP COUGHING (WAKES IN THE MIDDLE OF THE NIGHT COUGHING). HE PROVIDED THE PARTIAL LOT NUMBER OF W?K091 WITH AN EXPIRATION DATE OF 30 SEPTEMBER 2015. BIOTENE ORAL BALANCE GEL (2013 FORMULATION) IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).