BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TOUCH II

    MDR report key: 1063597 · Received June 20, 2008

    Report

    Report Number
    1823260-2008-04884
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTS LANCET DID NOT RETRACT INTO SOFT TOUCH DEVICE AFTER FIRING. 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 SOFT TOUCH II LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS STD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR METFORMIN 1000MG/DAY - 4 YEARS| ETODOLAC 800MG/DAY - 4 YEARS| SIMVASTATIN 400MG/DAY - 4 YEARS