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

Lot Number 1120156939

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  malfunction  

Event Description

It was reported that the patient had a reaction to the comfort hard soft splint that was issued.It is unclear when the patient received the device, when the patient first used the device, or when the reaction occurred or resolved.However, it is noted that the patient experienced irritation, metallic taste inside lip and around gum tissue.The irritation was not visible but can feeling.The device was worn for a few nights (exact dates unknown) and the symptoms went away after a few nights (exact dates unknown).The patient has an allergy to latex.Update: patient questionnaire received on (b)(6) 2023 with additional information.The device was delivered on (b)(6) 2023 and used that same evening.There was soft tissue irritation and a metallic taste in the mouth.It is unknown when the device was discontinued, but reaction resolved within 24hrs.There was no medical treatment required.There is an allergy to latex.With regard to the device: the provider was advised that a label will be sent to return appliance for further research.The device was cleaned using an ultrasonic device with denture cleaner.The patient rinsed with toothpaste and a brush.

Manufacturer Narrative

The device has been returned.Once the investigation is complete a supplemental report will be submitted.This complaint will be kept on record for track and trending purposes.

Manufacturer Narrative

Capa 2023-006 the device was returned, the investigation has been completed and the results are as follows: 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.Supplier (erkodent) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.An allergic reaction is possible.Additionally, erkodent reported no further complaints for this material lot.(please see attached coa) lot#ekd5.0-11481 was manufactured from september 14, 2020 and was assigned an expiration of september 2023.Stock product reviewed results: no stock product was available for review since the device was fabricated per physician's prescription only.Investigation method/results: complaint investigator reviewed the returned device.The results were summarized and the pictures were attached.(see below) 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 appeared clear and transparent with yellowish tint.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.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.Per the reported information, the patient has an allergy to latex.Ifu 9091 rev 5.0 (comfort h/s bite splint) contains the following statement in the warning section: "use only clear, cool water to wash the device.Do not clean or soak in mouthwash.Do not use denture cleanser.Do not use hot water (for cleaning).Do not use alcohol or hydrogen peroxide.Do not place in direct sunlight.Keep away from heat sources." ifu 9091 rev 5.0 (comfort h/s bite splint) contains the following statement for the cleaning procedures in the general safety and precautions section: "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.".

• Brand Name: COMFORT HARD-SOFT SPLINT
• Type of Device: THERMOFORM MOUTHGAURD
• 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 ; 9783130850
• MDR Report Key: 16863227
• MDR Text Key: 314495688
• Report Number: 3011649314-2023-00253
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1120156939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White