MAUDE Adverse Event Report: DENTSPLY PROSTHETICS LUCITONE LIQUID; DENTURE RELINING RESIN

Catalog Number 684309

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 02/07/2014

Event Type  Injury  

Event Description

In this event a customer reported that he had been using lucitone for years and recently began breaking out in sores when working with lucitone liquid, even when wearing gloves.The customer also reported that he has seen a dermatologist; however it is unknown if medical treatment was necessary.

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

• Brand Name: LUCITONE LIQUID
• Type of Device: DENTURE RELINING RESIN
• Manufacturer (Section D): DENTSPLY PROSTHETICS; york PA
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 3690520
• MDR Text Key: 15811995
• Report Number: 2515379-2014-00018
• Device Sequence Number: 1
• Product Code: EBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2014
• Device Catalogue Number: 684309
• Device Lot Number: 130531
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2013
• 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: 66 YR