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

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

Patient Problems Swelling (2091); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned.An investigation will be conducted once the sample has been returned and a supplemental report will be submitted.

Event Description

It was reported that a patient experienced an allergic reaction after using the ema appliance.After using the appliance for a few days after delivery, the patient developed swelling and ulcers where appliance contacted the inner cheek region, buccal and lingual tissue and lips.Upon experiencing the reaction, the patient stopped using the appliance; it took two weeks for the reaction to go away.The patient does not have any known allergies.

Manufacturer Narrative

The device has not been returned.However, the non-visual device investigation has been completed and the results are as follows: dhr results no dhr was available for review since 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: the device was not returned for investigation.Root cause the root cause cannot be explicitly determined.Customer did not return the device for investigation.Customer provided very limited information for this complaint.Ifu-012544 rev 1.0 (ema instruction for use) states in precaution "do not clean soak in water, ammonia, mouthwash, bleach, peroxide and denture cleaner".Ifu-012544 rev 1.0 also states in cleaning procedure "brush the device carefully with a soft toothbrush and use only clear cool water to rinse the device.Do not use soap to clean the appliance." however, the customer did not provide the information regarding how the patient was instructed to handle and maintain the device.Per ifu-0125444 rev 1.0, it contains the following statement in warning section: "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.".

• Brand Name: EMA
• Type of Device: ANTI-SNORING DEVICE
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 9944216
• MDR Text Key: 187117063
• Report Number: 3011649314-2020-00524
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K971794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

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?: No
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR