BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN AIR DRILL

    MDR report key: 303262 · Received November 6, 2000

    Report

    Report Number
    1226348-2000-00089
    Event Type
    Injury
    Date Received
    November 6, 2000
    Date of Event
    October 4, 2000
    Report Date
    November 6, 2000
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT DURING SURGICAL PROCEDURE; THE DRILL STOPPED THEN SUDDENLY STARTED WITH A JERKING MOTION AND CAUSED A TEAR IN THE DURA. PT IS REPORTED TO HAVE EXPERIENCED SOME TYPE OF PARALYSIS. CURRENT CONDITION IS UNKNOWN. ACCORDING TO USER FACILITY; INCIDENT REPORT HAS BEEN GENERATED AND IS EXPECTED TO BE MADE AVAILABLE TO CODMAN & SHURTLEFF, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN AIR DRILL MOTOR, DRILL, PNEUMATIC HBB CODMAN & SHURTLEFF, INC. NA 1049

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention