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 03/12/2021

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.Serial #: 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 and not implantable.

Event Description

The office called to report possible allergic reaction.It is reported that the patient is experienced swelling on tongue and cheeks.The patient wore the device for a few nights beginning (b)(6) 2021, with the reaction occuring (b)(6) 2021.The patient used otc advil and tylenol, with the reaction lasted two weeks after the discontinuation of the device.The patient discontinued the device (b)(6) 2021.There are no medical issues noted prior to the delivery nor was there an allergy test done prior.With regard to the device: it is unknown how the patient cleaned and stored the device, nor is it clear how the provider cleaned the device prior to its delivery.The patient was instructed to discontinue using the device.The symptoms went away after a day (date unknown).The patient has no medical or dental history prior to the delivery of the device.They are advised to see an allergist for definitive result.

Manufacturer Narrative

The 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: complaint investigator reviewed the returned device.An upper tray was returned in the original case.The results were summarized: roughness - the flange was smooth; internal/external surfaces were smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device did not appear discolored; clear/milky hue.General cleanliness - the returned device appeared to be clean, free of debris or foreign particles.The returned device was visually inspected and no defect or abnormality was observed.There was no evidence found to indicate that the reported issue was caused by the device itself.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." however, it is unknown how the patient cleaned and stored the device, nor is it clear how the provider cleaned the device prior to its delivery.Rpt 012574 rev.1.0 (clearsplint biocompatibility report) was conducted to report the results of biocompatibility testing clearsplint® nightguard materials complete with all dyes and metals used for construction of the device.Samples of clearsplint material were created meeting required surface areas and simulating the final device for biocompatibility testing.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.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer Contact: herbert crane ; 2144 michelson drive; irvine, CA 92612 ; 9495021907
• MDR Report Key: 12347406
• MDR Text Key: 267439321
• Report Number: 3011649314-2021-00285
• 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: 01/11/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: Asian