BEUDAMED
    FDA Adverse Event Other Summary report: N

    STYLUS

    MDR report key: 1220575 · Received October 31, 2008

    Report

    Report Number
    2618676-2008-00001
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    April 1, 2008
    Report Date
    October 24, 2008
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH
    Product Code
    GES
    PMA / PMN Number
    K822112
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. RESULTS - THE DEVICE WAS NOT RETURNED FOR EVAL. CONCLUSIONS - RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED FOR THE FINISHED GOODS LOT NUMBER REPORTED. NO RELEVANT FINDINGS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE BLADE HAD A "BARB" ON THE TIP. NO PT HARM/IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STYLUS SLIT KNIFE FULL HANDLE 2.75MM ANGLED GES SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH 52-2761 M280590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NONE MADE AVAILABLE