BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIPER DRILL

    MDR report key: 1345063 · Received March 16, 2009

    Report

    Report Number
    1037007-2009-00003
    Event Type
    Other
    Date Received
    March 16, 2009
    Report Date
    March 16, 2009
    Manufacturer
    GYRUS ENT
    Product Code
    HBE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL IS NOT COMPLETE.

    Description of Event or Problem · 1

    REPORTEDLY DURING A CASE, BROWN LIQUID LEAKED ONTO THE OPERATING SITE/PT. THE SURGEON HAD TO CLEAN THE SITE AND APPLY ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER DRILL SURGICAL DRILL HBE GYRUS ENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention