MAUDE Adverse Event Report: DENTAL EZ DENTAL EZ; DENTAL CHAIR

Model Number DENTAL EZ

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2016

Event Type  malfunction  

Event Description

Pt was seated in the dental chair when the simplicity dental light on the dental ez chair exploded causing the lights shield to shatter and parts of the light to fall onto the pt.Pt was wearing safety glasses as part of the doctors normal procedure.Pt then rinsed out mouth to make sure nothing had fallen into his mouth and debris was brushed off of him.

• Brand Name: DENTAL EZ
• Type of Device: DENTAL CHAIR
• Manufacturer (Section D): DENTAL EZ; bay minette AL 36507
• MDR Report Key: 5409517
• MDR Text Key: 37436871
• Report Number: MW5059965
• Device Sequence Number: 1
• Product Code: EAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DENTAL EZ
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR