MAUDE Adverse Event Report: KULZER GMBH - HQ TRANSLUX; ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION,

Model Number 2WAVE

Device Problems Use of Device Problem (1670); Electrical Shorting (2926)

Patient Problems Skin Erosion (2075); Burn, Thermal (2530); Full thickness (Third Degree) Burn (2696)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

The dentist wanted to insert the battery into the device for the first start up.She has removed the protective foil around the battery pack before inserting the rechargeable battery.Very probably, a shortage of the battery occurred during insertion and the shortage wire got very hot.By the scare, the device fell to the ground and separated into pieces.The dentist suffered a very small, 3rd degree burn on her left hand middle finger.She went to see a doctor and had to close the dental surgery for that afternoon.This incident is reported out of an abundance of caution according to 21 cfr 803 as the fda might define this as a serious injury.This is assumed to the fact that the dentist reports seeking secondary medical care for his slight burn and there is a likely hood of reoccurrence if the user defoils/ unpacks the protective foil around the lithium ion rechargeable battery pack.

Event Description

Very small 3rd degree burn on dentist's finger at trial of initial start-up of the device.

• Brand Name: TRANSLUX
• Type of Device: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION,
• Manufacturer (Section D): KULZER GMBH - HQ; leipziger strasse 2; hanau, 63450 ; GM 63450
• Manufacturer (Section G): KULZER GMBH - HQ; leipziger strasse 2; hanau, 63450 ; GM 63450
• Manufacturer Contact: albert erdrich ; leipziger strasse 2; hanau, 63450 ; GM 63450
• MDR Report Key: 9591322
• MDR Text Key: 175057263
• Report Number: 3005665377-2020-00001
• Device Sequence Number: 1
• Product Code: EBZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2WAVE
• Device Catalogue Number: 66055013
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• 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