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

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 08/06/2021

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.The patients weight is not provided as it is not taken at the time of the appointment.

Event Description

Received an email from the thermoform group regarding a new complaint.It was reported that patient had a reaction to the astron clear splint.The patient first used the device on (b)(6) 2021 with the reaction occurring (b)(6) 2021.The patient experienced soars/ulceration to the lip and tongue.The patient also notes that swelling in the soft palate.The patient took benadryl to aid in the swelling.The patient discontinued the use of the device on or about (b)(6) 2021 with the reaction lasting a few more days.The patient has an allergy to latex, several antibiotics, and several narcotics.With regard to the device:the provider cleaned the device prior to delivery based on the ifu supplied by glidewell.It is unclear how the patient cared for the device.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: dhr results: dhr not applicable.Device is 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 complaint investigator reviewed the returned device.An upper tray was returned in the original case.The results were summarized: roughness - the edge was smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device turned yellowish due to the usage.General cleanliness - the returned device was not clean, and debris can be observed.Case was returned in a good condition with label.Or 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, the customer did not provide the information regarding how the patient handled and maintained the device.

• Brand Name: ASTREON CLEAR SPLINT
• Type of Device: ASTRON CLEAR SPLINTS
• 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: 12573192
• MDR Text Key: 274956668
• Report Number: 3011649314-2021-00337
• 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: 01/28/2022

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: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Race: White