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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
Catalog Number 66055012
Device Problem Device Operates Differently Than Expected
Event Date 01/12/2016
Event Type  No Answer Provided  
Manufacturer Narrative

(b)(4). Although we have not established that the device caused or contributed to the event, we're reporting it 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 adverse reaction could not be determined. This is classified as a near incident in that the timely intervention of staff will prevent any serious damage or impairment to the receptionist's physical state. Device not yet returned.

 
Event Description

This occurred in (b)(6). Complaint from dental practice: handpiece 'smoking'. Receptionist burnt her finger on the device.

 
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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 GMBH
gruner weg 11
hanau, D-634 50
GM  D-63450
Manufacturer Contact
rita rogers
300 heraeus way
south bend , IN 46614
5742995409
MDR Report Key5408267
Report Number3005665377-2016-00001
Device Sequence Number1
Product CodeEBZ
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/12/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER HEALTH CARE PROFESSIONAL
Device Catalogue Number66055012
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/12/2016
Device Age2 mo
Event Location No Information
Date Manufacturer Received01/12/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 02/03/2016 Patient Sequence Number: 1
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