BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 1476292 · Received July 2, 2009

    Report

    Report Number
    1818910-2009-03406
    Event Type
    Malfunction
    Date Received
    July 2, 2009
    Date of Event
    June 5, 2009
    Report Date
    June 5, 2009
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K033563
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CEMENT WHEN PUT ON THE TRAY AND IMPACTED DID NOT STAY ATTACHED TO THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET GHV GENTAMICIN 40G 87LOD & MBB LOD DEPUY CMW NA 2803360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA