Description of Event or Problem · 1
TODAY, I APPLIED GLAXOSMITHKLINE'S NEW "ZINC FREE SUPER POLIGRIP" TO AN OVER-DENTURE THAT I AM WEARING WHILE HAVING DENTAL IMPLANTS PLACED. WHEN I ATE, THE POLIGRIP DISSOLVED AND THE OVER-DENTURE BECAME LOOSE. AS I REMOVED IT, A SMALL AMOUNT OF THE POLIGRIP STUCK TO MY OUTER, RIGHT JAW. I EXPERIENCED A SHORT SENSATION OF PAIN. LATER, I FOUND THAT SOME OF MY SKIN HAD BEEN TORN. I TRIED PHOTOGRAPHING THE INSIDE OF MY MOUTH - WITHOUT SUCCESS. SO, PLEASE LET ME DESCRIBE THE AFFECTED AREA: IN THE CREVICE BETWEEN MY JAW BONE AND THE INTERIOR OF MY CHEEK, THERE IS NOW A CIRCLE THAT IS SLIGHTLY MORE THAN A HALF CM IN DIAMETER. THE SKIN IS LIGHTER IN COLOR THAN THE SURROUNDING AREA; HOWEVER, THE VERY INNERMOST PART OF THE CIRCLE IS A DEEPER RED. THE AREA LOOKS SOMETHING LIKE A METAL WASHER WITH A HOLE IN THE CENTER. WHEN I RUN MY TONGUE OVER THE AREA, I CAN TELL THAT THE SKIN IS RAISED AND ROUGH. THERE IS A PROBABLY A POSSIBILITY THAT THE AFFECT IS FROM AN ALLERGIC REACTION; HOWEVER, THE PAIN THAT I FELT WHEN I REMOVED THE OVER-DENTURE MAKES ME THINK THAT THE POLIGRIP WHICH ADHERED TO MY MOUTH ACTUALLY TORE THE SKIN. FURTHER, I FEEL A LITTLE DISCOMFORT NEAR ONE OF THE TITANIUM IMPLANTS AND THE STAINLESS STEEL HEALING CAP AFFIXED TO IT. IF THE DISCOMFORT IS AN INDICATION THAT THE POLIGRIP DISRUPTED THE HEALING PROCESS OF THE IMPLANTS, THE INCIDENT BECOMES VERY SERIOUS AND, WHAT'S WORSE, VERY, VERY COSTLY IN TERMS OF HUMAN SUFFERING, TIME, AND MONEY. I BELIEVE THAT THE FDA HAS AN OBLIGATION TO LET THE PUBLIC KNOW THAT THE NEW ZINC-FREE POLIGRIP HAS THE POTENTIAL TO CAUSE HARM. THANK YOU FOR YOUR ATTENTION. I HOPE TO HEAR FROM YOU IN THE VERY NEAR FUTURE. DOSE OR AMOUNT: SINGLE APPLICATION. DATES OF USE: (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: OVER-DENTURE ADHESIVE USED DURING DENTAL IMPLANT WORK. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.