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

Device Problem Insufficient Information (3190)

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

Event Date 08/05/2021

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.The patient identifier was not provided when asked.The patients date of birth was not provided when asked.Sex: this information was not provided when asked.The patients weight is not provided when asked.Race/ethnicity: this information not provided when asked.Date of event: this information was not provided when asked.Serial # is not applicable with the exception of serial number as the device is manufactured by prescription.Section implant date-explant date is not applicable as the device is manufactured by prescription and not implantable.

Event Description

Received an email from the thermoform group regarding a new complaint.It was reported that the patient had a reaction to the ema device.It was reported that the appliance was worn a few minutes then removed it (no reaction reported to dentist).Then next night the patient wore the device the next night (date unknown).The reaction occurred on the gums are red and swollen with the lips tingling.The reaction lasted 16 hours after the discontinuation.The patient has a known allergy to sulfa.The patient was advised to have an allergy test.

Event Description

It was reported that the patient first used the device on (b)(6) 2021 with the reaction occurring (b)(6) 2021 immediately after the reaction.The patient discontinued use of the device (b)(6) 2021 and the reaction lasted approximately 22 hours.There was no medical intervention required.There is an allergy to penicillin and bactrim.The patient has a medical history of barrett's esophagus, hypothyroidism, celiac disease, hypertension, left bundle branch block, and cholesterol disease (type unknown).The following medications are taken: lisinopril, prilosec, metolazone, crestor, and levothyroxine.With regards to the device: patient was instructed to use warm water to clean.The provider cleaned with soap and water.

Manufacturer Narrative

Section a2: this information updated as it was not available at the initial submission.Section a3: this information updated as it was not available at the initial submission.Section a4: this information updated as it was not available at the initial submission.Section a6: this information updated as it was not available at the initial submission.Section b3: this information updated as it was not available at the initial submission.Section b5: additional information provided by the provider.Section b7: this information updated as it was not available at the initial submission.

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 button lot number originally requested was incorrect and was corrected by myerson prior to review.Additionally, the specific strap size returned with the device was identified prior to material lot review.· disc lot#: td051021 · button lot# : bn2b032521 exp.3/24 · bite pad lot#: bpb032921 · strap lot# (21mm yellow) : s041021 the myerson company found that there was no deviation during manufacture of the listed products and there were no similar reports for these lot numbers.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 not appear discolored and and was transparent.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.Per the reported information, the reaction occurred on the gums- were red and swollen with the lips tingling.The provider also noted the patient has a known allergy to sulfa and was advised to have an allergy test.The customer did not provide any information regarding how the patient handled and maintained the device.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: 12440582
• MDR Text Key: 270352740
• Report Number: 3011649314-2021-00310
• 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,Followup
• Report Date: 08/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2021
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: White