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 Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned.An investigation will be conducted once the sample has been returned and a supplemental report will be submitted.Weight: asked, but unknown.Date of event: asked, but unknown.Model number: not applicable.Catalog number: not applicable.Lot number: not applicable.Expiration date: not applicable.Udi number: not available.

Event Description

It was reported that a patient experienced an allergic reaction after using an xtra silent nite slide link appliance.According to the information provided by the doctor, the patient experienced swelling on the lips overnight on unknown date.It is unknown whether or not the patient has any known allergies.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: dhr results no dhr was available for review since the device was fabricated per physician's prescription only.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results complaint investigator reviewed the returned device and both upper and lower tray were returned with original case.The results were summarized below: roughness - the edge was smooth.Crack - no major cracks were found.Delamination - layers were intact and did not separated.Discoloration - no discoloration was observed.General cleanliness - the device was clean.Case was returned in a good condition with label.Accessories - the connector and bite tabs were all intact.Root cause.A root cause for this complaint cannot be explicitly determined.Ifu 7322 rev 2.0 (silent nite sleep appliance instructions for use) provides warning in precautions "do not soak the device in mouthwash; denture cleanser, hot water or alcohol; do not wash the device with soap, toothpaste or mouthwash; do not dry the device with a blow dryer; do not store in direct sunlight".However, the customer did not provide the information regarding how the patient handled and maintained the device.The returned device had no defect and there was no evidence indicating the reactions were contributed by the device.The device materials have been found to be biocompatible through the testing.There was no cytotoxic, sensitization, skin irritation, or oral mucosal irritation found per (rpt 9733 rev 1.0).

• 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: 9575563
• MDR Text Key: 180571963
• Report Number: 3011649314-2019-00807
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/14/2020
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 05/01/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR