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 Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Date of event was asked but the doctor did not remember the date.The device was received and the evaluation is anticipated.Once the investigation 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 for 2-3 weeks.The patient reported that his mouth was sore.The patient did not require any treatment for the symptoms.The symptoms resolved after about a week.The patient's status was reported to be normal and no symptoms.The patient has no pre-existing medical condition or any known allergy.There was no adjustment made to the nightguard.The mouthguard was cleaned using toothbrush and warm water prior to using.Another device with different material was made for the patient and the patient has not had any issue.

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 observed to be not clean with calcium deposits.The color was yellowish; however, the color turns yellowish due to normal usage.The case was returned in a good condition with the 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 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: 8724583
• MDR Text Key: 148942077
• Report Number: 3011649314-2019-00189
• 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: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 65