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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burning Sensation (2146)

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.

• 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, LLC; 300 heraeus way; south bend IN 46614 2517
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 6381112
• MDR Text Key: 69499464
• Report Number: 3005665377-2017-00001
• 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: 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 Received: 03/06/2017
• 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 Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/15/2017
• Date Manufacturer Received: 02/15/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other