TRAVERSE DENTAL CHAIR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for TRAVERSE DENTAL CHAIR manufactured by Engle Dental Systems.

Event Text Entries

[144136631] 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. (b)(4); dental mfr is aware that there is a defect. Document number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5086358
• MDR Report Key: 8577851
• Date Received: 2019-05-02
• Date of Report: 2019-04-10
• Date of Event: 2018-05-01
• Date Added to Maude: 2019-05-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TRAVERSE DENTAL CHAIR
• Generic Name: UNIT, OPERATIVE DENTAL
• Product Code: EIA
• Date Received: 2019-05-02
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ENGLE DENTAL SYSTEMS
• Manufacturer Address: 7205 NE EVERGREEN PKWY STE 100 HILLSBORO OK 97124 US 97124

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-05-02