BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM

    MDR report key: 2111065 · Received May 23, 2011

    Report

    Report Number
    9681138-2011-00127
    Event Type
    Other
    Date Received
    May 23, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 20, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP FREE IS MFG IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE (LOT NUMBER V10381). IT IS UNK IF THE PRODUCT WILL BE RETURNED FOR QA TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF TINGLING OF LIP IN A (B)(6) MALE PT WHO RECEIVED SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM ((B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE PT'S PAST MEDICAL HISTORY INCLUDED FEELING WEAK, HEART ATTACK, JAW PAIN, LOW BLOOD COUNT (NOS) AND STENT PLACEMENT. CONCURRENT MEDICATIONS INCLUDED CLOPIDOGREL BISULPHATE (PLAVIX), SIMVASTATIN, METOPROLOL, UNK AND ESOMEPRAZOLE (NEXIUM). ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP FREE (DENTAL). ON (B)(6) 2011, THE PT EXPERIENCED TINGLING OF LIP, JAW TINGLING, AND JAW NUMBNESS. ON AN UNK DATE, THE PT UNDERWENT ELECTROCARDIOGRAM AND HEART CATHETER PROCEDURE WHICH REVEALED A 70% BLOCKAGE. ON (B)(6) 2011, THE PT UNDERWENT CARDIAC STENT INSERTION. THE PT WAS HOSPITALIZED. THE PT WAS TREATED WITH ASPIRIN AND NITROGLYCERINE (NITROGLYCERIN). TREATMENT WITH SUPER POLIGRIP FREE WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE PURPOSE OF THIS CALL WAS TO INQUIRE IF USING SUPER POLIGRIP COULD CAUSE TINGLING IN LIPS, JAW AND NUMBNESS OF THE JAW. THE CONSUMER SPONTANEOUSLY MENTIONED THAT HE HAD TINGLING OF THE LIP, JAW AND NUMBNESS OF THE JAW AND WENT TO THE ER AND HAD A STENT PUT IN. THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF TINGLING LIP, JAW, NUMBNESS IN JAW AND THE PLACEMENT OF A STENT IN A (B)(6) MALE USING SUPER POLIGRIP. THE CONSUMER STATED THAT HE HAD BEEN USING SUPER POLIGRIP FOR YEARS AND PRIOR TO THAT HAD USED FIXODENT BUT FELT THAT SUPER POLIGRIP HELD BETTER. CONSUMER REPORTED THAT THE WEDNESDAY PRIOR TO THE REPORT, HE FELT A TINGLING IN HIS LIP AND JAW AND THAT HE WAS FEELING NUMBNESS IN HIS JAW. HE REPORTED THAT THIS OCCURRED ON AND OFF AND THEN AGAIN ON THURS IT HAPPENED AND AT THAT POINT, HE WENT TO THE ER. CONSUMER REPORTED THAT HE HAD AN EKG DONE WHICH WAS NEGATIVE. CONSUMER REPORTED THAT HE HAD A HEART CATH DONE WHICH SHOWED 70% BLOCKAGE OF AN ARTERY. CONSUMER REPORTED THAT HE HAD A STENT PLACED THE FRIDAY PRIOR TO THE REPORT. CONSUMER REPORTED THAT HE WAS DISCHARGED TO HOME THE SATURDAY PRIOR TO THE REPORT. CONSUMER REPORTED THAT HE WAS DISCHARGED WITH ASPIRIN AND NITROGLYCERINE TO TAKE AS NEEDED FOR CHEST PAIN OR TINGLING. CONSUMER REPORTED THAT THE DAY PRIOR TO THE REPORT, HE APPLIED THE SUPER POLIGRIP TO HIS DENTURE AND INSERTED THE DENTURE. CONSUMER REPORTED THAT HE THEN EXPERIENCED THE TINGLING AND NUMBNESS AGAIN. CONSUMER REPORTED THAT ONCE HE REMOVED THE DENTURE, THE EVENTS RESOLVED. CONSUMER REPORTED THAT ON THE DAY OF THE REPORT, HE AGAIN APPLIED THE SUPER POLIGRIP TO THE DENTURE AND INSERTED THE DENTURE INTO HIS MOUTH AND EXPERIENCED THE SAME EVENTS. CONSUMER IS UNSURE AT THE PRESENT TIME IF HE WILL CONTINUE TO USE THE SUPER POLIGRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM DOUBLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA V10381

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization SIMVASTATIN| METOPROLOL| NEXIUM| PLAVIX