BLEEDING [HEMORRHAGE], SKIN RIPPING OFF GUMS [GINGIVAL RECESSION], PAIN, SUFFERING. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REP AND DESCRIBED THE OCCURRENCE OF GINGIVAL RECESSION IN A (B)(6) FEMALE PT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNK) (POLIGRIP UNK) UNK FOR PRODUCT USED FOR UNK INDICATION. CONCURRENT MEDICAL CONDITION INCLUDED DIABETES, CAFFEINE CONSUMPTION (1 CUP OF COFFEE A DAY FOR MANY YEARS) AND DENTURE WEARER. ON AN UNK DATE, THE PT STARTED POLIGRIP UNK. ON (B)(6) 2015, AN UNK TIME AFTER STARTING POLIGRIP UNK, THE PT EXPERIENCED GINGIVAL RECESSION, HEMORRHAGE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), PAIN AND SUFFERING. ON AN UNK DATE, THE OUTCOME OF THE GINGIVAL RECESSION, HEMORRHAGE, PAIN AND SUFFERING WERE UNK. IT WAS UNK IF THE REPORTER CONSIDERED THE GINGIVAL RECESSION, HEMORRHAGE, PAIN AND SUFFERING TO BE RELATED TO POLIGRIP UNK. ADD'L INFO INCLUDED, THE CONSUMER REPORTED THAT SHE HAD SOME SKIN RIP OFF HER GUMS AND CAUSED BLEEDING WHEN SHE REMOVED HER DENTURES SHE USED POLIGRIP. SHE ALSO ADVISED THAT SHE EXPERIENCED A LOT OF PAIN AND SUFFERING BECAUSE OF THIS ISSUE. THE CONSUMER ALSO INDICATED THAT SHE WAS A FIRST TIME USER OF THIS PRODUCT.
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Patient 1
FOLLOW UP CASE WAS RECEIVED FROM THE CONSUMER ON 07/21/2015. THE CONSUMER RETURNED 1 TUBE OF POLIGRIP FREE AND PROVIDED THE LOT NUMBER AND EXPIRATION FOR THE PRODUCT, LOT V13444A AND EXPIRATION OCTOBER 2016. SHE REPORTED THAT HER CONDITION WAS GETTING BETTER SINCE THE INITIAL REPORT. SHE ALSO INDICATED THAT SHE HAD A HOSPITAL VISIT AND THEY COULD NOT DO ANYTHING SINCE THE INITIAL REPORT. SHE ALSO ADVISED THAT SHE INTENDED TO SEE HER DENTURIST FOR AN APPOINTMENT ON (B)(6) 2015. SHE REPORTED THAT SHE SAW AN HEALTH CARE PROFESSIONAL FOR HER CONDITION AND INDICATED THAT SHE WAS PRESCRIBED TRAMADOL FOR PAIN IN HER CONDITION. THE ACTION TAKEN OF POLIGRIP FREE WAS WITHDRAWN.