• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KULZER,LLC TRANSLUX® WAVE ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION Back to Search Results
Catalog Number 66055012
Device Problem Device Operates Differently Than Expected
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRANSLUX® WAVE
Type of DeviceACTIVATOR, 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 Key7523112
Report Number3005665377-2018-00001
Device Sequence Number1
Product CodeEBZ
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 Received05/17/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator DENTIST
Device Catalogue Number66055012
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/30/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/27/2018
Device Age1 mo
Event Location No Information
Date Manufacturer Received04/27/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/17/2018 Patient Sequence Number: 1
-
-