MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. ASTRON CLEAR SPLINT

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.Section dealing with model #, serial #, expiration date, catalog #, lot #, other # and udi # is not applicable with the exception of serial number as the device is manufactured by prescription.Implant date-explant date is not applicable as the device is manufactured by prescription not implantable.

Event Description

It was reported that the patient had an allergic reaction that took place in the intra oral affecting the gums causing swelling.The patient has a history of asthma.The patient also has several skin allergies to several soaps, lotions, ointments and adhesives.The patient first used the device on (b)(6) 2021 and noticed on (b)(6) 2021 that the gums were swollen and painful.The lower gum area had some "peeling." there was inflammation along with a rash around the upper and lower lip area.The patient discontinued using the device on (b)(6) 2021.The gum irritation lasted for two weeks, while the swelling and rash lasted one week after the discontinuation of the device.With regards to treatment, the patient rinsed with peroxyl and closys for 3 days after the reaction was noted.There were no allergy test prior to the delivery of the device.The patient current status is notes as residual gum irritation on the mandibular anterior.With regard to the device: the device required adjustment prior to the delivery and was rinsed with hot water to adjust.The patient cleaned the device using a toothbrush and toothpaste.It was then rinsed and stored dry in the case.

Manufacturer Narrative

The device has not been returned.However, the non-visual 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.No stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results: the customer stated the device was returned but has not been received to date.However, the non-visual device investigation has been completed.Root cause: a root cause for this complaint cannot be explicitly determined.Ifu 012579 rev 1.0 (clearsplint instruction for use) states "brush and floss before using clearsplint.After use, rinse the bite splint with water and store dry.Clean bite splint with soap and warm water only." ifu 012579 provides warning "do not clean or soak in mouthwash; do not use denture cleanser; do not place do not place the clearsplint in hot or boiling water or expose to excessive heat (such as direct sunlight).This may distort the appliance; do not use alcohol or hydrogen peroxide." per the reported information, the patient cleaned the device using a toothbrush and toothpaste.It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.Per rpt 012574 rev.1.0 (clearsplint biocompatibility report), the device materials have been found to be biocompatible through the testing.There was no cytotoxic, sensitization, skin irritation, or oral mucosal irritation found in any of the test articles.

• Brand Name: ASTRON CLEAR SPLINT
• Type of Device: ASTRON CLEAR SPLINT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2301dupont drive; suite 250; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2301 dupont drive; suite 250; irvine CA 92612
• Manufacturer Contact: herbert schoenhoefer ; 2301 dupont drive; suite 250; irvine, CA 92612 ; 9494402532
• MDR Report Key: 11876385
• MDR Text Key: 252396526
• Report Number: 3011649314-2021-00181
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White