BEUDAMED
    FDA Adverse Event Other Summary report: N

    A-DEC 6300 TRACK LIGHT

    MDR report key: 2799691 · Received September 12, 2012

    Report

    Report Number
    3015729-2012-00002
    Event Type
    Other
    Date Received
    September 12, 2012
    Date of Event
    August 11, 2011
    Report Date
    August 29, 2012
    Manufacturer
    A-DEC, INC.
    Product Code
    EAZ
    PMA / PMN Number
    K893044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEALER/TECHNICIAN FAILED TO PROPERLY INSTALL THE TRACK LIGHT WITH REQUIRED 4-POINT ATTACHMENT TO CEILING PER PUBLISHED INSTALLATION INSTRUCTIONS. ALL OTHER TRACK LIGHTS AT THIS DENTAL CLINIC WERE INSPECTED TO VERIFY PROPER INSTALLATION.

    Description of Event or Problem · 1

    THE REPORTED STATEMENT FROM THE DENTAL SERVICE TECHNICIAN: "BENCO SERVICE TECHNICIAN (B)(6) CALLED IN TO SAY THE LIGHT MENTIONED HERE (6300 TRACK LIGHT) ACTUALLY FELL DOWN OFF THE CEILING, STRIKING THE DOCTOR IN THE HEAD, AND GIVING HIM A CONCUSSION." INVESTIGATION DETERMINED THAT THE LIGHT WAS INSTALLED > 5 YEARS PREVIOUS TO THE INCIDENT. ADDITIONALLY, THE INSTALLATION INSTRUCTIONS SPECIFY THAT 4-POINT INSTALLATION IS REQUIRED AND THIS LIGHT WAS ONLY ATTACHED IN 3 POINTS. NO FURTHER TREATMENT WAS INDICATED FOR THE DENTIST THAT WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A-DEC 6300 TRACK LIGHT DENTAL LIGHT EAZ A-DEC, INC. 6300T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other