MAUDE Adverse Event Report: ULTRADENT PRODUCTS, INC. VALO GRAND; DENTAL CURING LIGHT

Catalog Number	5972
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	02/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Filing out of an abundance of caution due to the fact the valo was used during restorations which later turned out to be the restoration material used and cure times stated on the manufactures restoration material.Dr.Did not want to return light as he indicated the light functioned as intended.No device malfunction reported.
Event or Problem Description
Doctor has been using activa for about 2 years now, with no issues.Recently had 4 patients develop abscesses associated with small mo/do restorations placed approximately 6 months ago.The only change in protocol within the last six months is the recently purchased curing light.Doctor went from a valo corded to a valo cordless grand.Used the cordless on the fastest (curing) setting due to the fact that speed is key for pediatric patients.Email came in asking if there were any output differences between the corded and the cordless.

• Brand Name: VALO GRAND
• Common Device Name: DENTAL CURING LIGHT
• Manufacturer (Section D): ULTRADENT PRODUCTS, INC.; 505 west 10200 south; south jordan UT 84095
• MDR Report Key: 6382979
• Report Number: 1718912-2017-00002
• Device Sequence Number: 675948
• Product Code: EBZ
• UDI-Device Identifier: 00883205019219
• UDI-Public: 00883205019219
• Combination Product (Y/N): N
• PMA/510(K) Number: K160551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Dentist
• Device Catalogue Number: 5972
• Device Lot Number: BD44B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2017
• Initial Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Weight: 82