BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT ADHESIVE CREAM (CALCIUM ZINC GANTREZ SALT 44.4%, CELLULOSE GUM 20%) CRE

    MDR report key: 2100765 · Received May 19, 2011

    Report

    Report Number
    9617667-2011-00003
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    January 1, 2008
    Report Date
    April 27, 2011
    Manufacturer
    PROCTER & GAMBLE MFG. GMBH
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER THEREFORE UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    SUB-ACUTE SPINAL NERVE DEGENERATION [NERVE DEGENERATION]. ZINC POISONING [METAL POISONING]. BALANCE ISSUES [BALANCE DISORDER]. NUMB FROM THE WAIST DOWN [HYPOAESTHESIA]. TINGLING IN MY FEET [PARAESTHESIA]. FELL OVER [FALL]. FIXODENT - GOING THROUGH ONE TUBE EVERY TWO DAYS [DEVICE MISUSE]. CASE DESCRIPTION: ON (B)(6) 2011, A MALE CONSUMER OF UNK AGE REPORTED THAT HE HAD USED FIXODENT ADHESIVE CREAM, NUMBER AND FREQUENCY OF APPLICATIONS UNK, ON A DAILY BASIS, FOR THE PAST TEN YEARS AND HAD SUBSEQUENTLY DEVELOPED ZINC POISONING. HE REPORTED THAT HE HAD BEEN USING THE PRODUCT FOR HIS DENTURES FOR APPROX TEN YEARS: IN THE LAST FIVE YEARS HE HAD BEEN USING ONE TUBE EVERY TWO DAYS, APPLYING THE PRODUCT AFTER EVERY MEAL, MORNING AND EVENING. ON AN UNSPECIFIED DATE IN 2008 HE EXPERIENCED A FALL AND DEVELOPED TINGLING IN HIS FEET AND BALANCE PROBLEMS. HE VISITED HIS DOCTOR, WHO INITIALLY SUSPECTED A LEUKEMIA-LIKE DISEASE, HOWEVER ON FURTHER INVESTIGATION HE WAS DIAGNOSED WITH SUB-ACUTE NERVE DEGENERATION AND ZINC POISONING. THE CUSTOMER NOW USES A WHEEL CHAIR AND RECEIVED UNSPECIFIED TREATMENT. PRIOR TO HIS SYMPTOMS HE WAS NOT ON ANY ZINC-CONTAINING MEDICATION. HE NO LONGER USED THE PRODUCT. MEDICAL HISTORY: ALLERGIES- NONE; MEDICAL HISTORY - DENTURES. CONCOMITANT MEDICATION: NONE. THE OUTCOME OF THE CASE WAS: NOT RECOVERED/NOT RESOLVED. NO FURTHER INFO WAS PROVIDED. LATER ON (B)(6) 2011 A F/U CALL WITH THE CONSUMER OCCURRED. THE CONSUMER STATED THAT HE HAD BEEN USING NEARLY A TUBE OF FIXODENT A DAY DUE TO PROBLEMS WITH HIS DENTURES. HE STATED THAT HE WAS NUMB FROM THE WAIST DOWN, WAS IN A WHEEL CHAIR AND WAS HAVING UNSPECIFIED INJECTIONS. HE HAD BEEN ADMITTED TO HOSPITAL FOR UNSPECIFIED TESTS. THE OUTCOME OF THE CASE WAS: NOT RECOVERED/NOT RESOLVED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT ADHESIVE CREAM (CALCIUM ZINC GANTREZ SALT 44.4%, CELLULOSE GUM 20%) CRE DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG. GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S