BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT ADHESIVE CREAM, VERSION UNKNOWN

    MDR report key: 3142457 · Received April 30, 2013

    Report

    Report Number
    9617667-2013-00002
    Event Type
    Other
    Date Received
    April 30, 2013
    Date of Event
    January 1, 1993
    Report Date
    April 12, 2013
    Manufacturer
    PROCTER & GAMBLE MFG. GMBH
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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

    I AM SUFFERING FROM CHRONIC, NON SPECIFIC PERIPHERAL NEUROPATHY [NEUROPATHY PERIPHERAL]. DEMYELINATION OF THE PERIPHERAL NERVES [DEMYELINATION]. PINS AND NEEDLES IN HANDS AND FEET [PARAESTHESIA]. MUSCLE WEAKNESS IN HANDS AND FEET (MUSCULAR WEAKNESS]. PAIN IN HANDS AND FEET {PAIN IN EXTREMITY]. LOSS OF SENSE OF TOUCH IN HANDS/INABILITY TO FEEL OR HOLD SMALL ITEMS IN HANDS/LOSS OF FEELING IN MY FEET AND HANDS [HYPOAESTHESIA]. INABILITY TO STAND FOR ANY LENGTH OF TIME [DYSSTASIA]. INABILITY TO (STAND FOR ANY LENGTH OF TIME) OR WALK MORE THAN A SHORT DISTANCE/INABILITY TO WALK IN DARK [GAIT DISTURBANCE]. I STILL SUFFER FROM DEBILITATING MOBILITY ISSUES [MOBILITY DECREASED]. ZINC LEVELS BE SO HIGH (19.9 MCMOL/L) [BLOOD ZINC INCREASED]. FIXODENT - I HAVE BEEN USING 3-4/4-5 TIMES A DAY [DEVICE MISUSE]. CASE DESCRIPTION: A MALE CONSUMER OF AN UNSPECIFIED AGE REPORTED THAT HE USED FIXODENT ADHESIVE CREAM, VERSION UNKNOWN CREAM, 1 APPLICATION, 3-4 TIMES A DAY, ON UNSPECIFIED DATES FOR MORE THAN 20 YEARS, AND SINCE 1993 HAS EXPERIENCED PINS AND NEEDLES, MUSCLE WEAKNESS AND CONSTANT PAIN IN HIS HANDS AND FEET, LOSS OF SENSE OF TOUCH IN HANDS, INABILITY TO FEEL OR HOLD SMALL ITEMS IN HIS HANDS, INABILITY TO STAND FOR ANY LENGTH OF TIME OR WALK MORE THAN A SHORT DISTANCE, INABILITY TO WALK IN THE DARK (DUE TO NO SENSE OF KNOWING WHEN HIS FEET WERE TOUCHING THE SURFACE OR INDEED WHAT POSITION HIS FEET WERE IN). THE CONSUMER HAD UNDERGONE NERVE CONDUCTION TESTS, LUMBAR PUNCTURES AND A NERVE BIOPSY AND HAD BEEN ADVISED THAT HE WAS SUFFERING FROM CHRONIC, NON-SPECIFIC PERIPHERAL NEUROPATHY OR DEMYELINATION OF THE PERIPHERAL NERVES, ALTHOUGH THE PROGRESS OF THE DISEASE HAD BEEN SLOW IT HAD BEEN CONSTANT AND INCREASING IN SEVERITY. THE ONLY TREATMENTS OFFERED WERE STEROIDS, PAINKILLERS AND REGULAR PLASMA REPLACEMENT, ONCE THE SYMPTOMS BECAME "UNBEARABLE". THE CONSUMER HAS HAD TO GO FOR ANNUAL HOSPITAL CHECKUPS. ON (B)(6) 2012, THE CONSUMER STOPPED USING FIXODENT AND REQUESTED A BLOOD TEST FROM HIS GP WHICH TOOK PLACE ON (B)(6) 2012, ON (B)(6) 2013 BLOOD TESTS RESULTS SHOWED A LEVEL OF 19.9 MCMOL/L, A FURTHER BLOOD TEST ON (B)(6) 2013 SHOWED LITTLE CHANGE. THE CONSUMER REPORTED THAT SINCE THAT HE STOPPED USING FIXODENT, HIS CONDITION WAS IMPROVING. RELEVANT HISTORY: NO INFORMATION WAS PROVIDED. CONCOMITANT MEDICATION: NO INFORMATION WAS PROVIDED. THE OUTCOME OF THE CASE WAS: UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2013 A FOLLOW UP EMAIL WAS RECEIVED FROM THE CONSUMER REPORTING THAT HE USED FIXODENT ADHESIVE CREAM, VERSION UNKNOWN CREAM 1 APPLICATION, 4-5 TIMES A DAY, ON UNSPECIFIED DATES FOR MORE THAN 20 YEARS. THE CONSUMER REPORTED THAT SINCE HE STOPPED USING FIXODENT HIS CONDITION HAS IMPROVED AND HE WAS NOW PAIN FREE, HOWEVER HE CONTINUED TO EXPERIENCE DEBILITATING MOBILITY ISSUES AND A LOSS OF FEELING IN HIS FEET AND HANDS. RELEVANT HISTORY: NO INFORMATION WAS PROVIDED. CONCOMITANT MEDICATION: NO INFORMATION WAS PROVIDED. THE OUTCOME OF THE CASE WAS: PAIN IN EXTREMITY - RESOLVED, PERIPHERAL NEUROPATHY AND DEMYELINATION - IMPROVED, PARAESTHESIA AND MUSCULAR WEAKNESS - UNKNOWN ALL OTHER SYMPTOMS - NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2013, A FOLLOW-UP EMAIL WAS RECEIVED FROM THE CONSUMER STATING THAT HE HAD HIGH ZINC LEVELS. RELEVANT HISTORY: NO INFORMATION WAS PROVIDED. CONCOMITANT MEDICATION: NO INFORMATION WAS PROVIDED. THE OUTCOME OF THE CASE WAS: PAIN IN EXTREMITY - RESOLVED, PERIPHERAL NEUROPATHY AND DEMYELINATION - IMPROVED, PARAESTHESIA AND MUSCULAR WEAKNESS - UNKNOWN ALL OTHER SYMPTOMS - NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188687 FIXODENT ADHESIVE CREAM, VERSION UNKNOWN DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG. GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other