BEUDAMED
    FDA Adverse Event Other Summary report: N

    7 E DET RONGEUR LMBR 40 UP 3 MM

    MDR report key: 1516137 · Received October 26, 2009

    Report

    Report Number
    1226348-2009-00281
    Event Type
    Other
    Date Received
    October 26, 2009
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HTX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    REP REPORTED THAT JUST PRIOR TO SURGERY, THE SURGEON LOOKED AT (B) (6) AND NOTICED DEBRIS. HOSPITAL CLAIMS THAT THE INSTRUMENT IS HARD TO CLEAN. AS A RESULT THE SURGERY WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7 E DET RONGEUR LMBR 40 UP 3 MM RONGEUR, MANUAL HTX CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK