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); Swelling (2091); Reaction (2414)

Event Date 01/18/2019

Event Type  Injury  

Manufacturer Narrative

Patient's weight was asked but unknown.The device was requested to return for evaluation; however, the patient continues to wear the device and has not reported any issue.The reported device will not be returned for now.Once the evaluation is completed, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced an allergic reaction after wearing the comfort hard-soft bite splint.The patient reported of having rash, swelling and redness in the back of her throat.The patient experienced the reaction after using the mouthguard for almost 6 months.The doctor didn't know how long the reaction lasted after the patient stopped wearing the mouthguard.Per doctor's opinion, the reaction might have been caused by something else as the patient continued to wear the mouthguard without any issue.As of the date of this report, the doctor stated that the patient has no symptom and continues to wear the mouthguard.The patient has no pre-existing condition; however, the patient has "a lot of allergies" according to the doctor (specific allergies were not provided).The doctor made some adjustments to the occlusal side of the mouthguard.The patient was recommended to rinse the mouthguard with only water.The mouthguard will not be returned for now as the patient is wearing it.

Manufacturer Narrative

The mouthguard was not returned as it was reported that the patient kept the mouthguard for further use.To date, no further issues have been reported with the patient and this mouthguard.The doctor reported that the reaction might have been caused by "something else"; however, he did not provide the other possibilities.The mouthguard was manufactured per patient's prescription (rx).A review of the material lot was performed and no non-conformity nor defects were found.There was no manufacturing deviation or abnormality with the material lot.A series of biocompatibility tests were performed on a similar thermoformed mouthguard.It was found that the sleep device materials are biocompatible.Cytotoxicity test were 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.There were no device problems found with the test article.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: 8341939
• MDR Text Key: 136234429
• Report Number: 3011649314-2019-00011
• 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: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• 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: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR