BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMVAC SINGLE SYRING SET

    MDR report key: 1220397 · Received November 3, 2008

    Report

    Report Number
    1818910-2008-05038
    Event Type
    Injury
    Date Received
    November 3, 2008
    Report Date
    October 5, 2008
    Manufacturer
    DEPUY CMW
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SPEECH THERAPIST

    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

    CEMENT LEAKED OUT OF THE BACK OF THE SYRINGE DURING EXTRUDING CEMENT INTO FEMORAL CANAL. THE SURGERY WAS EXTENDED BY 120 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEMVAC SINGLE SYRING SET 87LXH LXH DEPUY CMW NA 08040039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA