BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT HYGIENE(CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GUM 20%) CREAM 1APPLIC

    MDR report key: 1993319 · Received February 4, 2011

    Report

    Report Number
    9617667-2011-00001
    Event Type
    Other
    Date Received
    February 4, 2011
    Report Date
    January 19, 2011
    Manufacturer
    PROCTER & GAMBLE MFG. GMBH
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    PHARMACIST

    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

    CHRONIC MYELOID LEUKEMIA [CHRONIC MYELOID LEUKEMIA]. ZINC INTOXICATION [METAL POISONING]. DYSPNOEA [DYSPNOEA]. TREMOR [TREMOR]. PARESTHESIA [PARESTHESIA]. DIZZY [DIZZINESS]. WEAK [ASTHENIA]. SWEATING [HYPERHIDROSIS]. PRODUCT MISUSE ("CONSUMED A TUBE OF FIXODENT IN 3 WEEKS") [DEVICE MISUSE]. CASE DESCRIPTION: A PHARMACIST REPORTED THAT A MALE CONSUMER OF UNK AGE USED FIXODENT HYGIENE CREAM, NUMBER AND FREQUENCY OF APPLICATIONS UNK, ON UNSPECIFIED DATE(S). THE CONSUMER CLAIMED TO HAVE BEEN INTOXICATED WITH ZINC FROM THE FIXODENT. A NUMBER OF INVESTIGATIONS WERE PERFORMED AND IT WAS REVEALED THAT HE WAS SUFFERING FROM ZINC INTOXICATION. ADDITIONALLY HE SUBSEQUENTLY EXPERIENCED PNEUMONIA. MEDICAL HISTORY: NO INFO WAS PROVIDED. CONCOMITANT MEDICATION: NO INFO WAS PROVIDED. THE OUTCOME OF THE CASE WAS: UNK. NO FURTHER INFO WAS PROVIDED. ON (B)(6)-2011, A F/U CALL WITH THE CONSUMER HIMSELF OCCURRED. HE STATED THAT HE USED FIXODENT HYGIENE CREAM, 1/APPLIC 1/DAY, BEGINNING (B)(6)-2010 UNTIL (B)(6)-2011 AND FIXODENT ADHESIVE CREAM, 1/APPLIC 1/DAY, BEGINNING (B)(6)-2010 UNTIL (B)(6)-2011 TO FIX HIS DENTURES. HE STATED THAT HE USED A TUBE OF THE PRODUCT EVERY THREE WEEKS. A FEW WEEKS AFTER USING THE PRODUCT HE BEGAN TO FEEL DIZZY AND WEAK, HE EXPERIENCED TREMORS, SWEATING, DYSPNOEA AND PARAESTHESIA. BY (B)(6)-2010 HIS SYMPTOMS HAD BECOME SO PRONOUNCED THAT HE VISITED A NEUROLOGIST. FOLLOWING A NUMBER OF INVESTIGATIONS HE DECIDED TO STOP USING THE PRODUCT; AFTER TWO DAYS HIS SYMPTOMS BEGAN TO IMPROVE. SUBSEQUENTLY HE WAS DIAGNOSED WITH CHRONIC MYELOID LEUKAEMIA. MEDICAL HISTORY: ALLERGIES - NONE, MEDICAL HISTORY - CERVICAL SPONDYLOSIS, DENTURE WEARER. THE OUTCOME OF THE CASE WAS: CHRONIC MYELOID LEUKEMIA AND ZINC POISONING - NOT RECOVERED/NOT RESOLVED; ALL OTHER SYMPTOMS - IMPROVED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT HYGIENE(CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GUM 20%) CREAM 1APPLIC DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG. GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SERMION/(B)(4)(NICERGOLINE)| TANAKAN/(B)(4)(GINKGO BILOBA EXTRACT)