BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIOS 3000 TRACK MOUNTED LIGHT

    MDR report key: 6989080 · Received October 30, 2017

    Report

    Report Number
    1017522-2017-00061
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    September 26, 2017
    Report Date
    October 3, 2017
    Manufacturer
    PELTON & CRANE
    Product Code
    EAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO PELTON & CRANE BUT RATHER VISUALLY EVALUATED BY A PELTON & CRANE AUTHORIZED DISTRIBUTOR. THE DISTRIBUTOR INFORMED PELTON & CRANE THE CEILING SUPPORT/BRACING WAS NOT ADEQUATE TO SUPPORT A DENTAL TRACK LIGHT AS REQUIRED BY PELTON & CRANES INSTALLATION INSTRUCTIONS. THEREFORE, THIS IS CONSIDERED INSTALLATION ERROR. PELTON & CRANES INSTALLATION INSTRUCTIONS AND WARNINGS CLEARLY IDENTIFY THE NEED TO PROVIDE ADEQUATE FRAMING TO SUPPORT AT LEAST 200 POUNDS IN REGARDS TO PROPER CEILING BRACING REQUIREMENTS TO SUPPORT THE PELTON & CRANE HELIOS TRACK MOUNTED DENTAL LIGHTS. PLEASE NOTE, THE DEALER NOR THE DOCTOR COULD PROVIDE THE SERIAL NUMBER OF THE PELTON & CRANE HELIOS TRACK MOUNTED DENTAL LIGHT THEREFORE PELTON & CRANE IS UNABLE TO DETERMINE THE SERIAL NUMBER OR THE AGE OF THE DEVICE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE DR. WAS POSITIONING A PELTON & CRANE HELIOS LIGHT WHEN THE COMPLETE LIGHT WITH TRACK FELL OFF THE CEILING HITTING THE DOCTOR ON THE HEAD CAUSING A LACERATION AND CONTUSION. THE DR. WENT TO THE EMERGENCY ROOM AND RECEIVED A TETANUS SHOT AND HAD THE LACERATION ON HIS HEAD GLUED TOGETHER.

    Description of Event or Problem · 1

    THE DR. WAS POSITIONING A PELTON & CRANE HELIOS LIGHT FOR USE WHEN THE COMPLETE LIGHT WITH TRACK FELL OFF THE CEILING HITTING THE DOCTOR ON THE HEAD CAUSING A LACERATION AND CONTUSION. THE DR. WENT TO THE EMERGENCY ROOM AND RECEIVED A TETANUS SHOT AND HAD THE LACERATION ON HIS HEAD GLUED SHUT. THIS MDR IS LINKED TO MANUFACTURER REPORT 1017522-2017-00060.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766145 HELIOS 3000 TRACK MOUNTED LIGHT DENTAL LIGHT EAZ PELTON & CRANE HL3T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention