MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. COMFORT HARD-SOFT SPLINT; THERMOFORM MOUTHGUARD

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

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 exception of serial number as the device is manufactured by prescription.The device is manufactured by prescription and not implantable.

Event Description

It was reported that the patient had a reaction to the comfort hard soft splint.The reaction that as noted was, "redness all throughout mouth area." it is not clear when the reaction occurred.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: dhr results: the dhr is not applicable for this device as 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: complaint investigator reviewed the returned device.An upper tray was returned in the original case.The results were summarized: roughness - the flange was smooth.Interior/exterior surfaces appeared smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device had a slight yellow hue but was still fairly clear and transparent.General cleanliness - the returned device was not clean and debris can be observed.Case was returned in a good condition with label.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." it is possible that reactions 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.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.All accessory materials and colors available for use in the device were tested.The findings in rpt 012574 rev.1.0 (clearsplint biocompatibility report) stated that "clearsplint material with blue dye & metal alloy was considered biocompatible when tested for cytotoxicity, sensitivity, oral mucosal irritation & dermal irritation.Clearsplint material with red dye cleared cytotoxicity, sensitivity & dermal irritation test but it was considered as minimal irritant for oral mucosal irritation.".

• Brand Name: COMFORT HARD-SOFT SPLINT
• Type of Device: THERMOFORM MOUTHGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson dr.; 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: 12217505
• MDR Text Key: 263154883
• Report Number: 3011649314-2021-00249
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121365
• 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: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• 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: 08/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• 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 Sex: Female