MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. COMFORT HARD-SOFT BITE SPLINT; THERMOFORMED MOUTHGUARD, COMFORT SPLINT

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

Patient Problems Rash (2033); Reaction (2414)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was asked and was advised to be some time in (b)(6) 2018.Follow-ups were made to request for device return; however, the device has not been returned to manufacturer yet.Additional follow up will be done to request for device 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 comfort bite splint.The patient developed a rash and dry lips shortly after wearing the mouthguard.The patient had been wearing the mouthguard for about 8 months before experiencing the reaction.Upon experiencing the issue, the patient stopped using the mouthguard per doctor's advice.The patient did not require any treatment for the reaction.The symptoms went away and the patient was reported to be doing fine.The patient has a history of tmj.The patient is allergic to cobalt chloride hexahydrate, fruit, nut and trees.The doctor did not make any adjustment to the mouthguard.The patient was recommended to clean the mouthguard using only water.

Manufacturer Narrative

The patient's device was not available for an evaluation as it was not received; however, tests were performed on a similar device.The reported mouthguard was fabricated per physician's prescription request.A review of the material lot was performed and no nonconformity was found.A series of biocompatibility tests were performed on a similar thermoformed mouthguard.It was found that the sleep device materials are biocompatible.Cytotoxicity test was 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.Without the device, physical structure testing could not be completed.This incident is being monitored, tracked, and trended.

• Brand Name: COMFORT HARD-SOFT BITE SPLINT
• Type of Device: THERMOFORMED MOUTHGUARD, COMFORT SPLINT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 8384382
• MDR Text Key: 137669499
• Report Number: 3011649314-2019-00023
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• PMA/PMN Number: K121365
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2019
• 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: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 64