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

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/11/2021

Event Type  Injury  

Event Description

It was reported that the patient had a reaction to the comfort hard soft splint.The device was issued (b)(6) 2021.It is unclear when the patient used this device.However, the patient experienced irritation of the gums and lips, both upper and lower.The patient discontinued the device (date unknown) it is unclear when the reaction resolved.However, there was slight erythema noted.The patient used benadryl otc as a treatment.The patient has an allergy to penicillin, sulfa, codeine, pollen allergies, cleaning chemical, some make up creams.There is a sensitivity to latex.With regards to the device: the device was cleaned with mild soap and cool water.The patient used water only.The device is scheduled to be returned.

Manufacturer Narrative

The device has not been returned.If/when there is more information provided, a supplemental report will be submitted.This is the second of three implant complaints for the same patient, see manufacturer report for the remaining complaint: 3011649314-2021-00496, 3011649314-2022-00114.

Manufacturer Narrative

Dhr results the dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.This investigation represents a second incident to the same device.Supplier (erkodent) previously reviewed the associated material lot in inv-03021 (comp (b)(4)) and confirmed no manufacturing deviation or abnormality.(see attachment) lot# e-pro 3.0-11600 (erkoloc-pro) was manufactured from march 29, 2021 and was assigned an expiration of march 2024.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.The device was returned, the investigation has been completed and the results are as follows: investigation methods/results this complaint investigation is for the second incident using the same device.Original device evaluation was previously conducted in inv-03021 (comp (b)(4)) and are as follows: complaint investigator reviewed the returned device.An upper splint was returned in the original case.The results were summarized: roughness - the flange was smooth.Internal aspect was smooth; external surface was rough especially on the occlusal area of the splint.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device appeared opaque and was not clear/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 9091 rev 4.0 (comfort h/s bite splint instruction for use) states "brush and floss your teeth before use.Rinse mouth well with clean water before inserting the device.If patient uses mouthwash, all traces of mouthwash should be removed by thoroughly rinsing out mouth with water.Rinse bite splint well with clean, cool water before and after use.Clean bite splint with clean, cool water only and let air dry." ifu provides warning "do not clean or soak in mouthwash; do not use denture cleanser, hot water, alcohol, hydrogen peroxide; do not place in direct sunlight".Per the reported information, the patient experienced irritation of the gums and lips, both upper and lower.It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.The provider reported the device was cleaned with mild soap and cool water.Additionally, the provider noted the patient has an allergy to penicillin, sulfa, codeine, pollen allergies, cleaning chemical, some make up creams.There is a sensitivity to latex.Supplier erkodent reviewed the incident details and determined an allergic reaction could not be ruled out.Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device (haley) following iso 10993 (biological evaluation of medical devices) and the device was evaluated for potential cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The haley test article was thermoformed with layers of erkodent material (erkoloc-pro and erkodur).The test results were listed below and summarized in biocompatibility report for haley sleep device (rpt 9733 rev 1.0) · for cytotoxicity testing, the test article extract showed no evidence of causing cell lysis or toxicity.

• Brand Name: COMFORT HARD-SOFT SPLINT
• Type of Device: THERMOFORM MOUTHGUARD
• 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: 13999667
• MDR Text Key: 289767918
• Report Number: 3011649314-2022-00113
• 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: 10/22/2022

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 10/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White