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 Type  Injury  

Manufacturer Narrative

Follow-up was made to ask for nightguard return for evaluation; however, the patient decided not to send the nightguard back.Once the evaluation is completed, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced an allergic reaction after using the xtra silent nite nightguard.The patient has had the nightguard for a while; however, the patient reported to wear the nightguard only when she was on a trip or vacation.During a trip, the patient experienced the reaction on the 2nd day of wearing the nightguard.The patient's mouth was reported to be swollen, tongue got "fat" and felt like having a rash.Upon experiencing the reaction, the patient stopped using the nightguard and the reaction lasted for 2 to 3 days.To treat the symptom, the patient rinsed with nystatin.The patient reported to be doing good.While the patient has no pre-existing condition, the patient reported to be allergic to wool.The doctor did not make any adjustment to the nightguard.The nightguard was rinsed with water prior delivering to the patient.The patient cleaned the nightguard using dawn dish soap.

Manufacturer Narrative

The device was not returned for evaluation.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 to the control article.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: 8692664
• MDR Text Key: 147773406
• Report Number: 3011649314-2019-00174
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR