MAUDE Adverse Event Report: DENTSPLY PROSTHETICS LUCITONE® HIPA DENTURE BASE LIQUID 500ML PACKAGE; RESIN, DENTURE, RELINING, REPAIRING, REBASING

Catalog Number 682012

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Date 01/22/2019

Event Type  Injury  

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.

Event Description

A potential patient allergic reaction to lucitone hipa denture base liquid was reported to chemtrec on (b)(6) 2019 by a clinician.The patient reported experiencing a potential reaction on (b)(6) 2019.The symptoms are unknown and no additional information has been provided.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: LUCITONE® HIPA DENTURE BASE LIQUID 500ML PACKAGE
• Type of Device: RESIN, DENTURE, RELINING, REPAIRING, REBASING
• Manufacturer (Section D): DENTSPLY PROSTHETICS; 570 west college avenue; york PA 17404
• MDR Report Key: 8380522
• MDR Text Key: 137510205
• Report Number: 2585114-2019-00001
• Device Sequence Number: 1
• Product Code: EBI
• Combination Product (y/n): N
• PMA/PMN Number: K161330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 682012
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other