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 Rash (2033); Swelling (2091); Reaction (2414)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

Patient's weight was asked but unknown.Request to have the device return was made; however, the device has not been returned for evaluation yet.Once the device is received and evaluation is completed, a supplemental report will be submitted.This report is for the upper tray of the night guard.Please reference 3011649314-2019-00013 ((b)(4)) for the lower tray.

Event Description

This report is for the upper tray of the xtra silent nite: it was reported that a patient experienced an allergic reaction after using the xtra silent nite night guard.Originally, the night guard was made for patient under (case # (b)(4)); however, the lower tray was returned for remake for better fit.A new lower tray was sent to patient under (case # (b)(4)).The doctor also made some adjustments to the lower left buccal area on the outside of new lower tray.After using the night guard for about 2 weeks, the patient reported of an allergic reaction.The patient developed rash on the cheeks and the lower lip was swollen.Upon experiencing the reaction, the patient stopped using the night guard and did not resume use.The patient took benadryl to treat the reaction.The symptoms went away after a couple of days.The patient was reported to be doing fine.The patient has no pre-existing condition; however, the patient has skin sensitivity and allergic to some detergents and penicillin.The patient was recommended to clean the night guard with water.

Manufacturer Narrative

Update was made to concomitant medical products - product was returned to the manufacturer on (b)(6)2019.The device 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 not separated.The nightguard's color turned yellow due to normal usage.The nightguard was returned in a good condition with label.Both of the connectors were intact and light cure was present fine.A review of the material lot was performed and no non-conformity nor defects were found.There was no manufacturing deviation or abnormality with the material lot.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.This incident is being monitored, tracked, and trended.

• 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: 8348865
• MDR Text Key: 136482245
• Report Number: 3011649314-2019-00012
• 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: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• 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: 03/15/2019
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR