Description of Event or Problem · 1
CONSUMER INITIATED USE OF EFFERGRIP DENTURE ADHESIVE CREAM 3 STRIPS DAILY, "YEARS AGO" TO SECURE CONSUMER'S DENTURES. CONSUMER HAS BEEN TAKING COUMADIN (WARFARIN SODIUM) 2.5 MG DAILY FOR 5 YEARS STARTING IN 2002 AS A "BLOOD THINNER." CONSUMER'S DENTIST "TOOK CONSUMER OFF COUMADIN FOR A DENTAL PROCEDURE, CONSUMER THEN HAD A STROKE IN 2002 SINCE THE STROKE, CONSUMER CANNOT TALK. THE CONSUMER ALSO REPORTED THAT CONSUMER SWALLOWS THE PRODUCT. USE OF BOTH PRODUCTS CONTINUES AND THE OUTCOME OF THE EVENTS IS NOT RECOVERED. COMPLAINT SAMPLE WAS RETURNED. RETAIN SAMPLE EVALUATION FOUND THE PRODUCT COMPARED TO PRODUCTS WITH A SIMILAR EXTRUSION VALUE, AND NO SEPARATION OF THE RETAIN SAMPLE WAS NOTED. THE LOT WAS MANUFACTURED ACCORDING TO ALL DOCUMENTED AND VALIDATED PROCEDURES. THE REPORTED LOT WAS MANUFACTURED AND RELEASED BY PFIZER AND DPT WITH A KNOWN HIGH EXTRUSION VALUES. AS PER DPT INVESTIGATION # 41R023 A HIGH EXTRUSION VALUE DOES NOT AFFECT THE SAFETY OR EFFICICY OF THE PRODUCT. THE EXTRUSION VALUE DETERMINES THE AMOUNT OF PRESSURE REQUIRED DISPENSING THE PRODUCT FROM THE TUBE, AND A VERY LOW EXTRUSION VALUE WOULD MAKE THE PRODUCT TOO DIFFICULT FOR THE TARGET CONSUMER TO DISPENSE. IT WAS DETERMINED BASED ON INVESTIGATION # 4IR023 THAT AN UPPER LIMIT ON THE EXTRUSION VALUE WAS NOT APPLICABLE. NO ROOT CAUSE FOR THE HIGH EXTRUSION VALUES NOTED WAS IDENTIFIED. IF A ROOT CAUSE IS IDENTIFIED AT A LATER DATE, EVALUATION OF POSSIBLE CORRECTIVE ACTIONS WILL BE UNDERTAKEN."