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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HERAEUS KULZER GMBH TRANSLUX WAVE ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

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HERAEUS KULZER GMBH TRANSLUX WAVE ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION Back to Search Results
Device Problem Device Operates Differently Than Expected
Event Date 02/15/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Although we have not established that the device caused or contributed to the event, we are reporting to be compliant with 21 cfr part 803 and out of an abundance of caution. Because the malfunction allegation could not be confirmed, the cause of the malfunction has not been determined. This is classified as a near incident in that the timely intervention of the staff prevented any serious impairment to her hand. Device not yet evaluated.

 
Event Description

This occurred in (b)(6). Patient complained that curing light was hot for anterior restorations. Tested by staff and left burn mark on hand.

 
Manufacturer Narrative

(b)(4). Although we have not established that the device caused or contributed to the event, we are reporting to be compliant with 21 cfr part 803 and out of an abundance of caution. Because the malfunction allegation could not be confirmed, the cause of the malfunction has not been determined. This is classified as a near incident in that the timely intervention of the staff prevented any serious impairment to her hand. On 3/21/2017 addendum/correction. Upon return of the translux power blue curing light in question, and thorough testing, the light is in excellent condition and no defect was detectable. This is a perception issue and would not be possible to cause any skin irritation.

 
Event Description

This occurred in (b)(6). Patient complained that curing light was hot for anterior restorations. Tested by staff and left burn mark on hand. On 3/21/2017 addendum/correction. Upon return of the translux power blue curing light in question, and thorough testing, the light is in excellent condition and no defect was detectable. This is a perception issue and would not be possible to cause any skin irritation.

 
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Brand NameTRANSLUX WAVE
Type of DeviceACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
Manufacturer (Section D)
HERAEUS KULZER GMBH
gruner weg 11
hanau, D-634 50
GM  D-63450
Manufacturer (Section G)
HERAEUS KULZER, LLC
300 heraeus way
south bend IN 46614 2517
Manufacturer Contact
rita rogers
300 heraeus way
south bend , IN 46614
5742995409
MDR Report Key6381112
Report Number3005665377-2017-00001
Device Sequence Number1
Product CodeEBZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER HEALTH CARE PROFESSIONAL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/03/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/15/2017
Event Location No Information
Date Manufacturer Received02/15/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/06/2017 Patient Sequence Number: 1
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