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

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

Patient Problems Rash (2033); Reaction (2414)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

The patient's weight, race and ethnicity were asked but unknown.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 the patient experienced allergic reaction using the xtra silent nite device.The patient developed rash a day after using the device.The rash was noted on the posterior of upper and lower lingual gingiva region.The patient was advised to stop using the device by the dentist.The rash lasted a few days and no treatment was required.There was some adjustments done to the device, but no specific location was provided.There was no information regarding how patient cleaned and maintained the device.The device was cleaned by the dentist using tap water prior to deliver to the patient.The patient was reported to be allergic to latex.The clinic confirmed that no latex was used on the patient.The patient has no pre-existing condition.

Manufacturer Narrative

The device was returned and evaluated for physical structure.The device was returned complete with the upper and lower tray and the two tray connectors.The device was manufactured per patient's prescription (rx).A visual inspection was performed and found the device's edges felt slightly rough, no cracks were found, no delamination present, no discoloration, and general cleanliness was fine, in good condition.A review of the material lot was performed and found no non-conformances.A series of biocompatibility test were performed on a similar thermoformed mouth guard, and it was found that the sleep device materials have been found to be biocompatible.There was no cytotoxic, sensitization, skin irritation, or oral mucosal irritation found in any of the test articles.The incident is being monitored, tracked, and trended.

Manufacturer Narrative

(b)(6).

• Brand Name: XTRA SILENT NITE
• Type of Device: ANTI-SNORING DEVICE
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• Manufacturer Contact: toan hoang ; 2212 dupont drive; suite p; irvine, CA 92612 ; 9492251235
• MDR Report Key: 7262059
• MDR Text Key: 99766121
• Report Number: 3011649314-2018-00007
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• 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: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR