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

Catalog Number 66055012

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burning Sensation (2146)

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.

• Brand Name: TRANSLUX® WAVE
• Type of Device: ACTIVATOR, 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 Key: 5408267
• MDR Text Key: 37420704
• Report Number: 3005665377-2016-00001
• Device Sequence Number: 1
• Product Code: EBZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 02/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 66055012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/12/2016
• Device Age: 2 MO
• Date Manufacturer Received: 01/12/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other