BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL STRAIGHT DRILL

    MDR report key: 570771 · Received February 4, 2005

    Report

    Report Number
    2027754-2005-00001
    Event Type
    Injury
    Date Received
    February 4, 2005
    Date of Event
    November 1, 2004
    Report Date
    January 25, 2005
    Manufacturer
    OSTEOMED
    Product Code
    KIJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 12/2003 RECEIVED COMPLAINT OF DRILL THAT OVERHEATED WITH POSSIBLE BURN. MULTIPLE ATTEMPTS MADE TO GATHER INFO BUT NOTHING RECEIVED TO INDICATE REQUIRED INTERVENTION. FURTHER FOLLOWUP IN APRIL 2004 - REQUESTED INFO. NONE PROVIDED AFTER 2 MORE ATTEMPTS. 3 ADDITIONAL ATTEMPTS IN JAN. 2005 DURING REVIEW OF FILES. NO DATA RECEIVED. IN 1/2005 RECEIVED CALL INDICATING PT HAD RECEIVED REVISION OF BURN IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL STRAIGHT DRILL DRILL KIJ OSTEOMED 450-0203 020021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention