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

Device Problem 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.

Event Description

It was reported that the patient had a reaction to the ema.It is unclear when the patient received the device, when the patient first used the device, or when the reaction occurred.However, it is noted that the device was worn for three (3) months and "swollen, bright red gingiva and tongue" were observed.The symptoms went away in about a day (date unknown).

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 and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.Supplier (the myerson company) reviewed the following material lot's associated with the device.Note - the specific strap size to the device was not provided and therefore could not be reviewed.· disc lot#: td121619 · button lot#: bn2011020 · bite pad lot#: ebp011020 · strap lot# estr233522 - straps could not be verified due to unavailability of information from the customer.The myerson company found that there was no deviation from purchasing of raw materials or manufacturing and there were no previous allergy complaints were reported concerning these lots.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results attempts to retrieve the device or determine the status of the device have been made but to no avail.However, the non-visual device investigation has been completed.Root cause a root cause for this complaint cannot be explicitly determined.Per the reported information, the patient experienced redness on buccal mucosa and also on top and bottom front gingiva.Ifu 012544 rev 2.0 (ema instructions for use) states the following in the warning section: "dentists should consider the medical history of the patients, including allergic reactions.Irritation of the mouth, tongue, and lips may occur." ifu 012544 rev 2.0 (ema instructions for use) states the following in the cleaning procedures section: "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." ifu 012544 rev.2.0 (ema instructions for use) provides the following in the precautions section: · do not soak in water · do not soak in ammonia · do not soak in mouthwash · do not soak in bleach · do not soak in peroxide · do not soak in denture cleaner the myerson company conducted a series of tests to evaluate the ema device for potential cytotoxicity, sensitization, and irritation/ intracutaneous toxicity.The test results were summarized by the supplier (the myerson company) in their biocompatibility testing summary report (op1 form #5, rev.A, mar.29 2019) and are as follows: as per the document, "determination of the biological evaluation tests required for myerson's elastic mandibular advancement device", it was decided that the following three tests needed to be done: · cytotoxicity · sensitization · irritation / intracutaneous toxicity quotations were received from biocompatibility laboratories and based on the guidance of the selected laboratories.Biocompatibility testing was completed during the first quarter of 2019.Eurofins/ product safety labs completed the cytotoxicity test on feb 13 2019.Nelson labs completed the irritation test on jan 17 2019.Eurofins/ product safety labs completed the sensitization test on mar 1 2019.The laboratories concluded that: 1) myerson's ema device is not cytotoxic.2) myerson's ema device is not an irritant.3) myerson's ema device is not a sensitizer.Based on these findings, myerson has found that the ema device is safe for its intended use.

• 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: 13094711
• MDR Text Key: 282824157
• Report Number: 3011649314-2021-00493
• 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: 08/14/2022

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 08/14/2022
• Was Device Evaluated by Manufacturer?: No
• 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