BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALUTE FIXATION DEVICE

    MDR report key: 883923 · Received July 18, 2007

    Report

    Report Number
    1213643-2007-00467
    Event Type
    Malfunction
    Date Received
    July 18, 2007
    Date of Event
    June 8, 2007
    Report Date
    July 18, 2007
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    GDW
    PMA / PMN Number
    K014286
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS FOUND TO PRODUCE STRAIGHT SHOTS WHICH APPEARS TO BE RELATED TO TIP WEAR.

    Description of Event or Problem · 1

    DEVICE HAS BEEN IN THE FIELD SINCE 4/21/2005 AND WAS INITIALLY REPORTED AS BEING BENT. UPON RECEIPT AND PRELIMINARY EVALUATION ON 6/18/2007, DEVICE WAS FOUND TO FIRE STRAIGHT SHOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALUTE FIXATION DEVICE GDW DAVOL INC., SUB. C.R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR