MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. EMA; ANTI SNORING NIGHTGUARD

Lot Number 1119471819

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If/when there is more information provided, a supplemental report will be submitted.The patients date of birth was not provided when asked.The patients weight is not provided when asked.Ethnicity/race:: this information not provided when asked.Date of event: this information was not provided when asked.Relevant tests / laboratory data:/ other relevant history, preexisting: this information was not provided when asked.Product information 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

It was reported that the patient had a reaction to the ema 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 experiencing burning sensation on tongue and buccal mucosa.The device was worn for 2-3 weeks (exact dates unknown).The symptoms went away after a few days of non-use (exact date unknown).Per the information there are no medical or dental history noted.

Manufacturer Narrative

The device has not been returned.However, the non-visual device evaluation has been completed and the results are as follows: dhr results the dhr was reviewed for case#1119471819 and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.Supplier (garreco) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.(see attachment) acrylic: lot# 940122 was manufactured from january 2022 and was assigned an expiration of january 2027.Supplier (myerson) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.(see attachment) disk: lot# td091522 was manufactured from september 15, 2022 and was assigned an expiration of september 15, 2023.Button: lot# bn2b053022 was manufactured from may 30, 2022 and was assigned an expiration of may 30, 2025.Bite pad: lot# b053022 was manufactured from may 30, 2022 and was assigned an expiration of may 30, 2025.Strap: lot# sa260360 was manufactured from june 16, 2022 and was assigned an expiration of june 16, 2025.Supplier (keystone) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.(see attachment) monomer: lot#mc8891 was manufactured from february 23, 2022 and was assigned an expiration of february 23, 2025.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results customer has not returned the product or provided an image for review.However, the non-visual device investigation has been completed.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.The patient has a history of sleep apnea, sinus issues, and an artificial joint (specific site unknown).Ifu-012544_3: dentists should consider the medical history of the patients, including allergic reactions, history of asthma, breathing, or respiratory disorders, or other relevant health problems and refer the patient to the appropriate healthcare provider before prescribing the device.Irritation of the mouth, tongue, and lips may occur.Regular dental follow-ups are recommended to review any side effects to avoid device breakage, allergic reaction, irritation, or discomfort.Ifu-012544_3 - cleaning procedures · brush and floss 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.· brush the device carefully with a soft toothbrush and use only clear cool water to rinse the device.· do not use soap to clean appliance.· minimize odor by letting the device dry during the day with the container lid open.Additional information: a2 age at time if event, date of birth, a3 sex, a4 weight, a6 race.

• Brand Name: EMA
• Type of Device: ANTI SNORING NIGHTGUARD
• 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: 16456624
• MDR Text Key: 310405694
• Report Number: 3011649314-2023-00087
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971794
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1119471819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 141 KG
• Patient Race: White