BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT DENTURE ADHESIVE CREAM

    MDR report key: 2931604 · Received January 22, 2013

    Report

    Report Number
    9681138-2013-00002
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    January 1, 2008
    Report Date
    January 18, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ASSESSMENT CAUSALITY: CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE OCCURRENCE OF THE INCIDENT COULD NOT BE RULED OUT. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2013-00002. POLIDENT DENTURE ADHESIVE CREAM IS MANUFACTURED IN (B)(4), AND IS MARKETED AS SUPER POLIGRIP IN THE UNITED STATES. NEITHER THE LOT NUMBER OR THE PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NEUROLOGICAL DISORDER IN (B)(6) MALE PT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (POLIDENT DENTURE ADHESIVE CREAM) FOR DENTURES (TO FIX THE BOTTOM PART OF HIS DENTURES). A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. TWENTY YEARS AGO, THE PT HAD TOTAL DENTURES FITTED IN HIS MOUTH. THE PT HAD PREVIOUSLY USED DOUBLE SALT DENTAL ADHESIVE CREAM. IN 1998 (15 YEARS AGO), THE PT STARTED DOUBLE SALT DENTAL ADHESIVE CREAM. APPROX 10 YEARS AFTER STARTING DOUBLE SALT DENTAL ADHESIVE CREAM, IN 2008, THE PT EXPERIENCED A "PAINFUL POINT IN HIS BACK" (BACK PAIN). THE PT WAS HOSPITALIZED FOR OVER 15 DAYS AND UNDERWENT A LUMBAR PUNCTURE, MRIS AND A COMPLETE EXAMINATION FROM HEAD TO FEET. ANOTHER WAS FOUND TO BE AT THE ORIGIN OF THE PAIN. AT FIRST, MULTIPLE SCLEROSIS HAD BEEN SUSPECTED. THE PT'S SYMPTOMS WORSENED. THE PT EXPERIENCED BALANCE DISORDERS WITH DIFFICULTY WALKING. IT WAS NOTED THAT THE PT COULD NOT STAY STANDING FOR A LONG TIME; HE VERY QUICKLY NEEDED TO SIT DOWN. THE PT WAS NOT ABLE TO DANCE ANYMORE OR BEND DOWN. THE PT RECEIVED AN UNSPECIFIED TREATMENT. IT WAS NOTED THAT AT THE END OF (B)(6) 2012, ONE OF THE PHYSICIAN'S FOLLOWING THE PT CONTACTED THE PT TO SAY THAT THIS CONDITION COULD PROBABLY BE DUE TO THE ZINC THAT USED TO BE CONTAINED IN DOUBLE SALT DENTAL ADHESIVE CREAM. ON (B)(6) 2013, THE PT UNDERWENT INFILTRATION. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30074 POLIDENT DENTURE ADHESIVE CREAM DOUBLE SALT DENTAL ADHESIVE CREAM KOO GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization