MAUDE Adverse Event Report: MARUS CRUSADER STAR BRITE LIGHT; DENTAL OPERATING LIGHT

Model Number 800-3

Device Problem Component Falling (1105)

Patient Problems Bruise/Contusion (1754); Burn(s) (1757); Injury (2348)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

A doctor was performing routine medical treatment to a patient when the lens heat shield/holder from his dental light fell off the light and hit the patient on the upper lip causing a small burn and bruise.

Manufacturer Narrative

The lens heat shield/holder from the dental light has a three prong locking mechanism which locks the lens heat shield/cover into place.The lens heat shield/cover has to be removed by the end user when cleaning the lens or replacing the halogen bulb during routine operator maintenance.The installation instructions, use and care instructions, and labeling clearly state to ensure the lens heat shield/holder is properly secure by snapping the part back into place.The dental light is over 21 years old and is past the expected life of the device.

• Brand Name: CRUSADER STAR BRITE LIGHT
• Type of Device: DENTAL OPERATING LIGHT
• Manufacturer (Section D): MARUS; 11727 fruehauf dr.; charlotte NC 28273
• Manufacturer Contact: frank ray, manager ; 11727 fruehauf dr.; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 3815384
• MDR Text Key: 4447863
• Report Number: 1017522-2014-00005
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 800-3
• Device Catalogue Number: 800-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1992
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR