BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1893170 · Received November 8, 2010

    Report

    Report Number
    1823260-2010-06617
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    I USED FIXODENT FOR ABOUT 10 YEARS. I HAVE NUMBNESS AND TINGLING IN MY ARMS AND LEGS. MY CONDITION IS PERMANENT. MY WRITING IS SHAKY. I AM ANEMIA, THE TASTE OF WATER IS BAD, I HAVE BACK TROUBLE, STANDING FOR ANY LENGTH OF TIME. I GET SICK TO MY STOMACH AND THROW UP. I GET LOOSE STOOLS, BAD TASTE, FEELS REAL BAD, SOMETIMES IT DON'T WORK A LOT OF TASTE BAD FEELING. CAN'T EAT VERY WELL CAUSE THE CREAM GETS LOOSE OR THE TASTE IS TOO BAD. DOSE OR AMOUNT: DENTURE CREAM, FREQUENCY: 3X DAY, ROUTE: ORAL. DATES OF USE: (B)(6) 2000 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DENTURE CREAM ADHESIVE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Description of Event or Problem · 1

    CALLER REPORTS LANCET IS PROTRUDING FROM MULTICLIX DEVICE CAP. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE PRODUCT, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS GWX032

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR