BEUDAMED
    FDA Adverse Event Summary report: N

    TRAVERSE DENTAL CHAIR

    MDR report key: 8577851 · Received May 2, 2019

    Report

    Report Number
    MW5086358
    Date Received
    May 2, 2019
    Date of Event
    May 1, 2018
    Report Date
    April 10, 2019
    Manufacturer
    ENGLE DENTAL SYSTEMS
    Product Code
    EIA
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE ARE A DENTAL OFFICE AND PURCHASED A TRAVERSE DENTAL CHAIR FROM ENGLE DENTAL SYSTEMS. THIS CHAIR IS THE ONLY TYPE OF CHAIR MANUFACTURED THAT TRAVERSES INTO A LAYING DOWN POSITION WHILE ALSO MOVING FORWARD. THE CHAIR HAS A METAL MOUNT FOR OTHER EQUIPMENT THAT IS POSITIONED IN SUCH A WAY THAT IT CAN (AND HAS) CLOSED ON AN AREA WHILE IN MOTION THAT COULD SERIOUSLY INJURE A PT'S APPENDAGE. THE MFR WAS NOTIFIED BUT FAILED TO REPORT OR RESOLVE THE ISSUE BECAUSE WE ARE THE ONLY OFFICE THAT BROUGHT UP THE ISSUE. THEY ACKNOWLEDGED THE ISSUE BUT HAVE NOT REPORTED THE DESIGN FLAW, ARE IGNORING THE SAFETY CONCERN, AND HAVE NOT ALTERED THE DESIGN. THEY ARE STILL SELLING IT KNOWING THERE IS A DEFECT AND RISK TO PUBLIC SAFETY. THE MFR RECENTLY SENT A LETTER STATING THAT THEY DETERMINED THAT THE INJURY COULD OCCUR OUTSIDE OF THE NORMAL OPERATION OF THE CHAIR WHICH IS NOT ACCURATE, THE CHAIR WAS DESIGNED IN A WAY TO ALLOW THE POTENTIAL FOR INJURY WITH THE PROPER AND INTENDED USAGE OF THE CHAIR. HTTPS://ENGLEDENTAL.COM, 800 547 1906; DENTAL MFR IS AWARE THAT THERE IS A DEFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369509 TRAVERSE DENTAL CHAIR UNIT, OPERATIVE DENTAL EIA ENGLE DENTAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1