BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN (CALCIUM ZINC CANTREZ SALT 33-59

    MDR report key: 2223827 · Received August 18, 2011

    Report

    Report Number
    9617667-2011-00004
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    January 1, 2009
    Report Date
    October 26, 2010
    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

    DAMAGE TO OUR CLIENTS LEG MUSCLES [MUSCLES INJURY]. WITHOUT ANY SENSATION FROM BELOW HER CHEST [SENSORY LOSS]. CASE DESCRIPTION: A LAW FIRM REPORTED THAT A FEMALE CONSUMER OF UNK AGE USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNK, NUMBER AND FREQUENCY OF APPLICATIONS UNK, FOR 15 YEARS. THEY REPORTED THAT SINCE 2009, SHE EXPERIENCED IRREVERSIBLE DAMAGE TO HER LEG MUSCLES AND A LOSS OF SENSATION FROM BELOW THE CHEST, LEAVING HER WHEELCHAIR DEPENDENT. MEDICAL HISTORY: NO INFO WAS PROVIDED. CONCOMITANT MEDICATION: NO INFO WAS PROVIDED. THE OUTCOME OF THE CASE WAS NOT RECOVERED/NO RESOLVED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN (CALCIUM ZINC CANTREZ SALT 33-59 DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG. GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability