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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

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 device.It is unknown when the patient first used the device.The patient experienced swelling of the mucosa of the lip (lateral border) and the tip of the tongue right away.The mucosa felt "sore." the patient discontinued the device on (b)(6) 2021.The reaction lasted 2-3 days after the discontinuation of the device.The provided a steroid cream and palliative care.The patient has an allergy to shellfish and a history of post tachycardia syndrome (pots) as well as mild mitochondrial disease.Since the reaction, there has not been to an allergist.The patient current status is noted as "fine.No residual symptoms.With regards to the device: the prior to the delivery of the device the provider rinsed the device and "cleaned" it with a toothpaste and toothbrush.The patient was instructed to care for it the same way.

Manufacturer Narrative

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 (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#: td122820, · button lot# : bn2b032521 , · bite pad lot#: bpb120520, · strap group lot#: estra242955d.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 : complaint investigator visually inspected the returned device.The returned parts included both upper and lower tray in a myerson case.The results were summarized: roughness - the flange and exterior surfaces were smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device did appear discolored and was semi-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.Per the reported information, the patient experienced swelling of the mucosa of the lip (lateral border) and the tip of the tongue right away.The mucosa felt "sore." the provider also noted the patient has an allergy to shellfish and a history of post tachycardia syndrome (pots) as well as mild mitochondrial disease.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 (b)(6) 2019.Nelson labs completed the irritation test on (b)(6) 2019.Eurofins/ product safety labs completed the sensitization test on (b)(6) 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: 12531981
• MDR Text Key: 273303162
• Report Number: 3011649314-2021-00336
• 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

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/25/2021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White