BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT DENTURE ADHESIVE, EXTRA HOLD

    MDR report key: 3931396 · Received June 26, 2014

    Report

    Report Number
    1530449-2014-00004
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    June 16, 2014
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS PROVIDED BY THE REPORTER, LOT CHECK AND BATCH RETAIN TESTING PENDING.

    Description of Event or Problem · 1

    GUMS BECAME INFECTED [GINGIVITIS]. REMOVING PARTIAL CAUSES BLEEDING OF GUMS [GINGIVAL BLEEDING]. PEELING-GUMS [ORAL MUCOSAL EXFOLIATION]. SKIN GETS REMOVED FROM GUMS REMOVING PARTIAL [GINGIVAL INJURY]. REMOVING PARTIAL CAUSES PAIN IN GUMS [GINGIVAL PAIN]. BLISTERS-GUMS [GINGIVAL BLISTER]. WHOLE MOUTH SWOLLEN [OEDEMA MOUTH]. WHOLE FACE SWOLLEN [SWELLING FACE]. (FIXODENT GETS GUMMY) MAKES IT DIFFICULT TO REMOVE PARTIAL [DEVICE DIFFICULT TO USE]. REAPPLIES FIXODENT AFTER DRINKING SOMETHING COLD, SOMETIMES APPLIES A LITTLE MORE (MORE THAN ONCE A DAY) [DEVICE MISUSE]. FIXODENT GETS GUMMY (MAKES PARTIAL HARD TO REMOVE), POWER CLUMPY [DEVICE PHYSICAL PROPERTY ISSUE]. HEADACHES [HEADACHE]. PROBLEMS SLEEPING [INSOMNIA]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT FEMALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, EXTRA HOLD POWDER UNKNOWN APPLICATIONS TO HOLD HER PARTIAL PLATE DENTURE AND REPORTED THE FOLLOWING: FOR THE LAST 1.5 TO 2 YEARS THE CONSUMER HAS EXPERIENCED DIFFICULTY REMOVING HER PARTIAL, FIXODENT POWDER BECAME GUMMY AND IT BECAME DIFFICULT TO REMOVE HER PARTIAL; SHE HAS REAPPLIED FIXODENT AT TIMES AFTER DRINKING SOMETHING COLD OR IF AT A RESTAURANT (MORE THAN ONCE A DAY) AND SOMETIMES APPLIES A LITTLE MORE; HER PARTIAL WAS DIFFICULT TO REMOVE AND SHE EXPERIENCED BLEEDING OF GUMS, SKIN REMOVED FROM GUMS, PAIN IN GUMS, BLISTERS ON GUM AREAS, AND PEELING GUMS. THE CONSUMER VISITED HER DENTIST WHO FELT HER SYMPTOMS WERE CAUSED BY USE OF THE PRODUCT. THE DENTIST PROVIDED HER WITH AN UNSPECIFIED MOUTHWASH TO NUMB THE AREA AND KEEP ARE FROM INFECTION BUT DID NOT ADVISE DISCONTINUING USE OF THE PRODUCT. THE CONSUMER MENTIONED ABOUT 4-5 MONTHS AGO HER GUMS BECAME INFECTED BECAUSE OF THIS. HER WHOLE MOUTH AND FACE BECAME SWOLLEN. THE CONSUMER VISITED HER DENTIST WHO SENT HER TO THE EMERGENCY DEPARTMENT. THE CONSUMER WAS ADMITTED TO THE HOSPITAL OVERNIGHT AND TREATED WITH INTRAVENOUS ANTIBIOTICS. THE CASE OUTCOME WAS NOT RECOVERED / NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - TOOTH LOSS - HAS HAD A PARTIAL SINCE AGE 11 WHEN A GUNSHOT TO THE MOUTH TOOK OUT 4 OF HER UPPER TEETH. MEDICAL HISTORY - DENTURE WEARER - HAD ABOUT 4 DIFFERENT PARTIAL PLATE DENTURES MADE IN THE LAST 7 YEARS TO FIND ONE THAT FITS. EXACT PRODUCT TAKEN PREVIOUSLY: YES. NO FURTHER INFORMATION WAS PROVIDED. (B)(6) 2014: CONSUMER FOLLOW UP CALL TO (B)(4): THE CONSUMER REPORTED SHE WAS ALSO EXPERIENCING HEADACHES AND PROBLEMS SLEEPING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372972 FIXODENT DENTURE ADHESIVE, EXTRA HOLD DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO. 3344U4

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O