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

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

Patient Problems Inflammation (1932); Reaction (2414)

Event Date 08/20/2018

Event Type  Injury  

Manufacturer Narrative

Patient's weight was asked but unknown.Follow-up attempts were made to request to have the nightguard return for evaluation.The clinic informed that they already sent it out; however, the nightguard has not been received yet.Once the nightguard is received and evaluation is completed, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced an allergic reaction after using xtra silent nite nightguard for a week.After using the nightguard for a week, the patient had inflammation on the lip and tongue.Upon experiencing the reaction, the patient stopped wearing the nightguard and the symptom went away after a week.The patient did not require any treatment for the reaction.The patient was reported to be doing ok.Per doctor's provided information, the patient tends to rub his tongue against the nightguard.The patient has no known pre-existing condition or allergy.The doctor did not make any adjustment to the nightguard prior delivering to patient.The patient was recommended to clean the nightguard using only water.

Manufacturer Narrative

Update was made to concomitant medical products- product was returned to manufacturer on (b)(6)2018.The nightguard was manufactured per patient's prescription (rx) and returned for an analysis.A visual inspection was performed on the returned nightguard.The edges of the nightguard were smooth.No major cracks were found.Nightguard's layers were intact and were not separated.The nightguard's color turned yellow due to normal usage.The nightguard was returned in a very clean condition.Case was also returned in good condition with label.Both of nightguard's connectors were intact and fine.A review of the material lot was performed and no manufacturing deviation or abnormality were found.A series of biocompatibility tests were performed on a similar thermoformed mouthguard.It was found that the sleep device materials are biocompatible.Cytotoxicity test were completed on a test article and there was no evidence of toxicity nor cell lysis.There was no evidence of erythema and no edema observed for skin irritation test.Sensitization test showed no evidence of the test article causing delay dermal contact nor oral mucosal irritation.There were no device problems found with the test article.It was reported that the patient tended to rub his tongue against the nightguard.Based on the available information, the inflammation might have been caused by the patient pushing his tongue and lip against the appliance.The complaint could not be confirmed.This incident is being monitored, tracked, and trended.

• Brand Name: XTRA SILENT NITE
• Type of Device: ANTI-SNORING MOUTHGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 8194504
• MDR Text Key: 131369670
• Report Number: 3011649314-2018-00447
• 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: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2018
• 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: 12/12/2018
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR