BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIGEN

    MDR report key: 1406164 · Received June 22, 2009

    Report

    Report Number
    1020279-2009-00595
    Event Type
    Injury
    Date Received
    June 22, 2009
    Date of Event
    June 1, 2009
    Report Date
    June 18, 2009
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LYT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAIL CAP COULD NOT BE INSERTED DURING SURGERY AND THE SURGEON HAD TO USE A SECOND NAIL CAP. SURGERY TIME WAS EXTENDED BY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIGEN NAIL CAP / LYT LYT SMITH & NEPHEW, INC. 08DM14079

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization