BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIGRIP

    MDR report key: 1951116 · Received December 30, 2010

    Report

    Report Number
    MW5018844
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    April 1, 2003
    Report Date
    December 17, 2010
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD TO HAVE DENTURES IN APPROX 2003 AND USED POLIGRIP FOR FOUR YEARS AND THEN USE FIXODENT OR POLIGRIP TO THIS DATE. (B)(6) 2010, I STARTED EXPERIENCING TINGLING, NUMBING, STINGING IN MY LEFT ARM. MY FEET ALSO WILL GO TO SLEEP VERY EASILY. ON (B)(6) 2010, A BLOOD TEST WAS DONE, THE RESULT IS HIGH ZINC LEVELS. DOSE OR AMOUNT: #1 & #2: DENTURE CREAM. FREQUENCY: #1 & #2: 1-2 DAILY. ROUTE: #1 & #2: ORAL. DATES OF USE: #1: (B)(6) 2003. #2: (B)(6) 2007. DIAGNOSIS OR REASON FOR USE: #1 & #2: DENTURE ADHESIVE. EVENT ABATED AFTER USE: #1 & #2: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP NONE KOL UNKNOWN
    2 FIXODENT NONE KOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| S