BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LFTIII TACK MOUNTED LIGHT

    MDR report key: 2850064 · Received November 26, 2012

    Report

    Report Number
    1017522-2012-00030
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 29, 2012
    Manufacturer
    PELTON & CRANE
    Product Code
    EAZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION BY THE LOCAL PELTON AND CRANE REPRESENTATIVE, IT WAS DETERMINED THE ROLL PIN WAS NOT INSTALLED BY THE DISTRIBUTOR DURING INSTALLATION. THE ROLL PIN WILL PREVENT THE LIGHT FROM UNSCREWING FROM THE POLE AFTER INSTALLATION. THE PELTON AND CRANE INSTALLATION INSTRUCTIONS CLEARLY STATES TO PROPERLY INSTALL THE ROLL PIN DURING INSTALLATION OF THE TRACK LIGHT. THE INSTALLATION INSTRUCTIONS ALSO LIST WARNINGS TO INSURE THE ROLL PIN IS PROPERLY INSTALLED.

    Description of Event or Problem · 1

    A DENTIST WAS POSITIONING A PELTON AND CRAIN DENTAL LIGHT FOR USE WHEN THE LIGHT UNSCREWED FROM THE COLUMN ASSEMBLY AND FELL DOWN TOWARDS THE FLOOR, HITTING THE DENTIST ON THE SHOULDER, CAUSING A LACERATION. THE DENTIST APPLIED A STERI-STRIP BAND-AID FOR THIS INJURY. A SECOND PERSON (PATIENT) WAS INVOLVED IN THE EVENT. PLEASE SEE MDR# 1017522-2012-00029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LFTIII TACK MOUNTED LIGHT DENTAL LIGHT EAZ PELTON & CRANE LFT111

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other