MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. XTRA SILENT NITE; ANTI-SNORING NIGHTGUARD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Irritation (1941); Swelling (2091); Reaction (2414)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

Request was made to have the reported nightguard return for evaluation; however, the nightguard has not been returned as of late.Once the evaluation is completed, a supplemental report will be submitted.This report is for the 2nd of 3 reported events: please reference 3011649314-2019-00162 ((b)(6)) for the 1st event.Please reference 3011649314-2019-00170 ((b)(6)) for the 3rd event.

Event Description

This report is for the 2nd event: it was reported that the patient continued use of a silent night, night guard for a few more nights.During this time, the patient reported that the tongue was slightly inflamed and the patient's gums were very red, by morning.Upon experiencing the reaction, the patient stopped using the nightguard for a couple of weeks.After the patient stopped using the nightguard for a couple of weeks due to reaction, the patient attempted to use the xtra silent nite nightguard again.On the 2nd try, the patient experienced swollen inflamed lips, irritation on the corners of the mouth and tongue looking red and fissured.The patient experienced these symptoms while using it for the entire week.Everything (symptoms) gradually went away after the patient stopped using the nightguard.The patient did not require any treatment for the reaction.The patient was reported to be doing better now.The patient has history of hodgkin's lymphoma (treated with chemo and radiation) and currently taking levothyroxine.The patient also has penicillin and brazil nuts allergies.No adjustment was made to the nightguard.The nightguard was cleaned using only water and toothbrush.No disinfectant was used.

Manufacturer Narrative

The xtra silent nite was manufactured per patient's prescription (rx) and returned for analysis.A visual inspection was performed on the returned device.The edge was smooth and no major cracks were found.The device's layers were intact and did not separate.The device was very clean with no discoloration observed.Both connectors were intact.The device and case were returned in a good condition with the original label.A batch/lot review for the associated material showed no manufacturing deviations or abnormalities.Glidewell research team and namsa conducted a series of testing on erkodent material (erkoloc-pro and erkodur) following iso 10993 (biological evaluation of medical devices) and the device was evaluated for potential cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The test results were listed and summarized in rpt 9733 rev 1.0.· for cytotoxicity testing, the test article extract showed no evidence of causing cell lysis or toxicity.· for skin irritation, there was no erythema and no edema observed on the skin test.· for sensitization testing, the test article extracts showed no evidence of causing delayed dermal contact sensitization.· the test article showed nonirritant to the oral mucosa as compared this complaint will be kept on record for track and trending purposes.

• Brand Name: XTRA SILENT NITE
• Type of Device: ANTI-SNORING NIGHTGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 8633239
• MDR Text Key: 145837003
• Report Number: 3011649314-2019-00169
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K972424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 82