MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT INC. COMFORT SPLINT; THERMOFORM MOUTHGUARD

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

Patient Problems Pain (1994); Peeling (1999)

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned.An investigation will be conducted once the device/sample has been returned and a supplemental report will be submitted.Age - asked, but unknown.Date of birth - asked, but unknown.Weight: asked, but unknown.Ethnicity: asked, but unknown.Race: 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 a comfort splint (upper).According to the information provided by the doctor, the patient experienced peeling in the lips and sore gums on unknown date.It is unknown whether or not the patient has any known allergies.

Manufacturer Narrative

The investigation has been completed and the results are as follows: device history record: no dhr was available for review since the device was fabricated per physician's prescription only.Returned sample inspected: the device was not returned for investigation.Root cause: a root cause for this complaint cannot be explicitly determined.Ifu 9091 rev 1.0 (thermoformed mouthguards instruction for use) states to use only clear, cool water to wash the device.Ifu provides warning "do not clean or soak in mouthwash; do not use denture cleanser, hot water, alcohol, hydrogen peroxide; do not place in direct sunlight".It is possible that swelling, redness and irritation could be caused by mouthwash, toothpaste, or soaking material.However, the customer did not provide the information regarding how the patient handled and maintained the device.A series of testing were performed on a similar device.The device (model variant) was evaluated for cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The test articles showed no evidence of causing cell lysis or toxicity.This complaint will be kept on record for track and trending purposes.

• Brand Name: COMFORT SPLINT
• Type of Device: THERMOFORM MOUTHGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 9164839
• MDR Text Key: 161565995
• Report Number: 3011649314-2019-00562
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• 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: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention