MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. ASTRON CLEAR SPRINT; THERMOFORM MOUTHGUARD

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

Patient Problems Sore Throat (2396); Patient Problem/Medical Problem (2688)

Event Date 12/17/2019

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.The patients weight is not provided as it is not taken at the time of the appointment.Is not applicable to this device with the exception of the lot number.

Event Description

It was reported that the patient had a sore throat while wearing the astron clear splint.The patient has a history of thyroid disease for which she takes medication, but the specific med is not known at this time per the provider.She also has a history of cold sores (hsvi).The patient is allergic/sensitive to latex, metal and penicillin.The patient was presented with the device on (b)(6) 2019 with instructions on how to clean and care for the device.On (b)(6) 2019, the patient returned for adjustments.There were no complaints at that time.The patient returned for a general cleaning on (b)(6) 2019 and informed the hygienist that, "she had a sore throat that she believes was caused by the device.She also states that, she has a sensitivity to plastic." the provider then decides to re-make the device.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: dhr results: no dhr was available for review.The device was fabricated per physician's prescription only.Stock product reviewed results: no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results: the returned parts included a lower tray in an original case.The results were summarized below: roughness - the edge was smooth.No readjustment was observed.Crack - no major cracks were found.Delamination - layers were intact and did not separated.Discoloration - no discoloration.The device appears to be clear without any color additives.General cleanliness - very clean.Case was returned in a good condition with label.Root cause: the root cause cannot be explicitly determined.Per premarket notification 510(k) summary for clearsplint (k111828), it contained the following statement in proposed instruction, "caution: an allergy test is recommended prior to placing (appliance) in a dental cavity." according to the record, patient was sensitive/allergic to plastic, latex, metal and penicillin.Review of sds provided by astron (see attachment) indicated clearsplint does not contain any materials that were reported to be sensitive/allergic to the patient.The patient provided her medical history, but prescriber did not provide any evidence that indicated the reported issue was contributed by the device.Per proposed instruction provided from k111828, astron dental corporation suggested "briefly place appliance in warm tap water before inserting in mouth." according to the record, patient followed the instructions to maintain and clean her device.Per supplement data from k111828, the clearsplint was found to be biocompatible.

• Brand Name: ASTRON CLEAR SPRINT
• Type of Device: THERMOFORM MOUTHGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine, ca CA 92612
• MDR Report Key: 9588273
• MDR Text Key: 175229165
• Report Number: 3011649314-2019-00808
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• PMA/PMN Number: K111828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR