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

Model Number HBT

Device Problem Device Fell (4014)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Pelton & crane is in the process of gathering more information from the complaint issued to the (b)(6) court of justice.Once obtained we will submit a follow-up report with the results of our evaluation.

Event Description

Pelton & crane became aware of an incident regarding a pelton & crane lftii dental light through an action filed by the ontario superior court of justice alleging the light fell on them prior to a procedure causing the dentist physical and mental injuries.

• Brand Name: LIGHT FANTASTIC II
• 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: sharon miles ; 11727 fruehauf drive; charlotte, NC 28273 ; 7049270678
• MDR Report Key: 8394602
• MDR Text Key: 137955566
• Report Number: 1017522-2019-00004
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HBT
• Device Catalogue Number: LFTII
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/1989
• 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): Other