BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-PRO

    MDR report key: 2211177 · Received August 15, 2011

    Report

    Report Number
    1823260-2011-04337
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE POINT OF CARE COORDINATOR FOUND 2 LANCETS THAT WERE EXPOSED AND STICKING OUT OF THE END IN A BOX OF SAFE-T-PROS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-T-PRO LANCET FMK ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1