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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENGLE DENTAL SYSTEMS TRAVERSE DENTAL CHAIR UNIT, OPERATIVE DENTAL

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ENGLE DENTAL SYSTEMS TRAVERSE DENTAL CHAIR UNIT, OPERATIVE DENTAL Back to Search Results
Device Problems Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2018
Event Type  No Answer Provided  
Event Description
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).
 
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Brand NameTRAVERSE DENTAL CHAIR
Type of DeviceUNIT, OPERATIVE DENTAL
Manufacturer (Section D)
ENGLE DENTAL SYSTEMS
7205 ne evergreen pkwy
ste 100
hillsboro OK 97124
MDR Report Key8577851
MDR Text Key144136631
Report NumberMW5086358
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2019
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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