MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES, LLC LIGHT FANTASTIC +; DENTAL LIGHT

Model Number H3

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

The dental light is over 43 years old and past the life of the device.The dentist is disposing of the light and buying a new one.

Event Description

A dentist was moving a pelton & crane dental light away after use when the light arm assembly broke and fell down towards the ground hitting the patient on the shin causing a laceration.The dentist said the patient required stitches as a result of the incident.

• Brand Name: LIGHT FANTASTIC +
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): KAVO DENTAL TECHNOLOGIES, LLC; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): KAVO DENTAL TECHNOLOGIES, LLC; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 7567287
• MDR Text Key: 110028838
• Report Number: 1017522-2018-00017
• 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 faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: H3
• Device Catalogue Number: LF+
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/1975
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR