MAUDE Adverse Event Report: KULZER,LLC TRANSLUX® WAVE; ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Catalog Number 66055012

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This malfunction is reportable according to 21 cfr 803.As this sort of malfunction may cause or contribute to a death or serious injury, if the malfunction were to reoccur."malfunction" means the failure of a device to meet its performance specifications or otherwise perform as intended.This is a singular event.Practitioner complained of smell of burnt plastic.Neither patient, practitioner nor third party was injured, but we are reporting out of an abundance of caution.If this were to reoccur the heat generated may cause injury.

Event Description

Curing light hand piece heated up, melted voltage meter on pcb.

• Brand Name: TRANSLUX® WAVE
• Type of Device: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
• Manufacturer (Section D): KULZER,LLC; leipziger strabe 2; hanau, hessen 63450 ; GM 63450
• Manufacturer (Section G): KULZER,LLC; leipziger strabe 2; hanau, hessen 63450 ; GM 63450
• Manufacturer Contact: rita rogers ; 4315 south lafayette blvd.; south bend 46614 ; 5742995409
• MDR Report Key: 7523112
• MDR Text Key: 109024829
• Report Number: 3005665377-2018-00001
• Device Sequence Number: 1
• Product Code: EBZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: 66055012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2018
• Device Age: 1 MO
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other