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

Catalog Number 66055012

Device Problems Labelling, Instructions for Use or Training Problem (1318); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 03/06/2015

Event Type  Injury  

Event Description

(b)(6) called me (b)(4) on friday evening to inquire about a new battery for a doctor in her territory.She said the doctor removed the white cover on the battery and shocked him self when he tried to re attach the wires.She sent me the attached email with the doctor's contact information.Dds removed the cover from his battery and the battery came apart.The light was sent on (b)(4) 2014 and is in warranty.He said he attempted to place the pieces back together and the wires arced and short circuited and a flash of light was seen and he said it felt like a white hot razor blade was pressed against his thumb causing a burn.I apologize for any problem he experienced and asked if he sought medical attention.He said he did not.I asked how his thumb is today and he said it is fine.He sent pictures of the battery and his thumb.I assured him this will be sent to our home office to ensure steps are taken so this does not happen again to another office.

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.Narrative: directions for use, page 7, states: do not disassemble or modify the battery! one li-ion mh12210 battery was received, in a box marked "defective battery." battery had been disassembled into 6 parts and packed with the white cover which had originally protected all of the parts.The positive end showed a charred mark next to where the flat wire had been broken.

• Brand Name: TRANSLUX WAVE
• Type of Device: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
• Manufacturer (Section D): HERAEUS KULZER GMBH; gruner weg 11; hanau, D-63 450; GM D-63450
• Manufacturer (Section G): HERAEUS KULZER GMBH; gruner weg 11; hanau, D-63 450; GM D-63450
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 4648897
• MDR Text Key: 5596780
• Report Number: 3005665377-2015-00001
• Device Sequence Number: 1
• Product Code: EBZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 66055012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/09/2015
• Device Age: 21 MO
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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
• Patient Age: 60 YR