BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALUTE FIXATION DEVICE

    MDR report key: 884326 · Received July 20, 2007

    Report

    Report Number
    1213643-2007-00490
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    June 22, 2007
    Report Date
    July 20, 2007
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    GDW
    PMA / PMN Number
    K03323
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCT WAS FOUND TO PRODUCE STRAIGHT SHOTS WHICH APPEARS TO BE RELATED TO TIP WEAR. THE DEVICE HAS BEEN IN THE FIELD SINCE 4/25/2005.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FIRING 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