BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTRODUCER SET

    MDR report key: 641350 · Received October 14, 2005

    Report

    Report Number
    1820334-2005-00256
    Event Type
    Other
    Date Received
    October 14, 2005
    Date of Event
    September 9, 2005
    Report Date
    September 15, 2005
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE FOR IMPLANTING A PACE MAKER, THE DR RECEIVED A NEEDLE STICK INJURY WHILE USING THE PEELAWAY INTRODUCER RED NEEDLE SAFETY DEVICE. WHILE PUTTING A CURVED SUTURE NEEDLE AWAY, THE CURVED NEEDLE PUNCTURED THE SIDE OF THE RED PLASTIC CAP AND PUNCTURED THE DR'S LEFT MIDDLE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRODUCER SET SHEATH SET DYB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other