MAUDE Adverse Event Report: DENTSPLY PROSTHETICS LUCITONE 199 DENTURE BASE RESIN; RESIN, DENTURE, RELINING, REPAIRING, REBASING

Catalog Number 688211

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/25/2016

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.Retention product powder and liquid were tested and dhr's evaluated for abnormalities, no issues detected from either investigation.

Event Description

A patient reported an allergic reaction to her full upper denture reline on (b)(6) 2016 to chemtrec.The patient reported experiencing numbness of the lips, palate swelling, headaches and reports a strong chemical taste.Removal of the device alleviates the patient's symptoms.

• Brand Name: LUCITONE 199 DENTURE BASE RESIN
• Type of Device: RESIN, DENTURE, RELINING, REPAIRING, REBASING
• Manufacturer (Section D): DENTSPLY PROSTHETICS; 570 west college avenue; york PA 17404
• Manufacturer (Section G): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5743291
• MDR Text Key: 48000735
• Report Number: 2585114-2016-00001
• Device Sequence Number: 1
• Product Code: EBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: 688211
• Device Lot Number: 151009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2015
• 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
• Patient Age: 61 YR