BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 474400 · Received July 29, 2003

    Report

    Report Number
    1226348-2003-00168
    Event Type
    Injury
    Date Received
    July 29, 2003
    Date of Event
    June 24, 2003
    Report Date
    July 3, 2003
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DISPOSABLE PERFORATOR FAILED TO DISENGAGE AND PLUNGED INTO THE PT'S SINUS CAUSING BLEEDING. THE CODMAN PERFORATOR, WHEN ATTACHED TO THE MIDAS REX LEGEND, DID NOT STOP WHEN IT WENT THROUGH BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DISPOSABLE PERFORATOR COMPOUND DRILL HBF CODMAN & SHURTLEFF, INC. NA EV900

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 26-1221 MFG MEDWATCH REPORT #1226348-2003-00169,| 26-1221 MFG MEDWATCH REPORT #1226348-2003-00170.