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

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

Patient Problems Erythema (1840); Irritation (1941); Reaction (2414)

Event Date 05/20/2018

Event Type  Injury  

Manufacturer Narrative

The device was received and the evaluation is anticipated.Once the investigation is completed, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced an allergic reaction after using the tap iii appliance.The patient used the appliance for about 16 days prior to developing the reaction.On the day of the event, the patient experienced reaction shortly after wearing the appliance.The patient had irritation and erythema on the area (anterior buccal mucosa or the inside of the cheeks) that made contact with the device's metal.The patient stopped using the device immediately upon experiencing reaction.The symptoms lasted a few days after the patient stopped using the appliance.The patient was not given any treatment for the reaction.The patient's status was reported to be clear.The patient has no known allergies.The patient has no relevant pre-existing condition.The dentist made adjustment(s) on the mandibular protrusion area of the device prior delivering to the patient.The device was cleaned using brush and toothpaste.The device was also cleaned using the same method prior delivering to the patient.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: device history record: no dhr was available for review since the device was fabricated per physician's prescription only.Suppliers (erkodent) reviewed the associated material lots and confirmed no manufacturing deviation or abnormalities.Supplier (airway management) confirmed the metal accessories lot was in compliance.Lot# ep2mm11217 (erkoloc-pro) was manufactured from 1/18/2018 and was assigned with 5 years expiration.Lot# e2mm11196 (erkodur) was manufactured from 9/12/2017 and was assigned with 5 years expiration.Returned sample: complaint investigator reviewed the returned parts with production on 10/1/18.The returned parts included an upper and lower tray, and a tap case.The adjustment key was not returned for investigation.The results were summarized below.Roughness - the edges of the appliance (both upper/lower) felt smooth.Crack - no crack was found.Delamination - layers were intact and did not appear separated.The metal plate appeared to be discolored.Discoloration - the color of the tray turned yellowish due to the normal usage.General cleanliness - very clean and no white deposits or cell debris present with the device.Accessories - metal accessories were inspected.Hook, locking screw, adjustment screw, bite pad and metal plate were intact root cause: a root cause for this complaint cannot be explicitly determined.Per "warnings" section from patient instruction booklet sent to the patient, it contains the following statement, "allergic reaction may be encountered in people who are sensitive to nickel or self-curing acrylic." however, it was reported the patient has no known allergies or any pre-existing conditions.It was reported the patient used toothpaste to clean the tap 3 device.Per "homecare instructions" section from patient instruction booklet, it contains the following statement, "each morning after use, thoroughly clean your tap3 appliance using a regular soft toothbrush, cool water and antibacterial liquid soap.Do not use hot water." the device's caution label states that "inspect the tap device prior to each use.If any parts of the device become loose or damage, return to your prescriber.Discontinue use if you observe material separation, material degradation, or damage parts." however, the device was inspected and confirmed the device has no defect or abnormalities.Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device following iso 10993 (biological evaluation of medical devices) and the device was evaluated for potential cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The test results were listed below and summarized in biocompatibility report (rpt 9733 rev 1.0).· for cytotoxicity testing, the test article extract showed no evidence of causing cell lysis or toxicity.· for skin irritation, there was no erythema and no edema observed on the skin of the animals treated with the test article.· for sensitization testing, the test article extracts showed no evidence of causing delayed dermal contact sensitization.· the test article showed nonirritant to the oral mucosa as compared to the control article.The sleep device materials have been found to be biocompatible through the testing.There was no cytotoxic, sensitization, skin irritation, or oral mucosal irritation found in any of the test articles.This complaint will be kept on record for track and trending purposes.

• Brand Name: TAP III
• Type of Device: ANTI-SNORING DEVICE, TAP III
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 7661576
• MDR Text Key: 113155684
• Report Number: 3011649314-2018-00210
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K062951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• 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: 06/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 54