BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTEC SPG 3-1/2X4 STR 10S 32 PLY

    MDR report key: 1883963 · Received May 1, 2009

    Report

    Report Number
    1018120-2009-00028
    Event Type
    Malfunction
    Date Received
    May 1, 2009
    Report Date
    April 9, 2009
    Manufacturer
    COVIDIEN
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2009. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2009 THAT A CUSTOMER HAD AN ISSUE WITH THE VISTEC GAUZE. THE CUSTOMER REPORTS THE GAUZE WAS LINTING IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTEC SPG 3-1/2X4 STR 10S 32 PLY GAUZE GDY COVIDIEN 7320 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK