BEUDAMED
    FDA Adverse Event Other Summary report: N

    P25LBTK PENCAN FULL SPINAL

    MDR report key: 1172651 · Received September 12, 2008

    Report

    Report Number
    9611612-2008-00012
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    October 15, 2007
    Report Date
    September 11, 2008
    Manufacturer
    PAJUNK GMBH MEDIZIN TECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K911202
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT IS NOT AN ADMISSION THAT THIS DEVICE OR ANY OTHER DEVICE DISTRIBUTED BY PAJUNK (B) (4) IS OR WAS DEFECTIVE OR DANGEROUS IN ANY WAY, OR CAUSED OR CONTRIBUTED TO ANY PT INJURY. NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORDS AND THE RAW MATERIAL HISTORY FILES FOR THE REPORTED DEVICE TYPE SHOWED NO RECORDS QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. PAJUNK IS OEM AND CONTRACT MFR. THE DEVICE IS SUPPLIED BULK TO (B) (4) AND PACKAGED/ FINISHED IN THE U.S. NO FURTHER INFO AVAILABLE. PAJUNK CONSIDERS THIS FILE AS CLOSED.

    Description of Event or Problem · 1

    ACC. TO CUSTOMER: "INTRODUCER NEEDLE BENT IN TRAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P25LBTK PENCAN FULL SPINAL KIT, CONDUCTION ANAESTHETICS CAZ PAJUNK GMBH MEDIZIN TECHNOLOGIE A200710104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other