MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. TAP-D; DREAM TAP

Lot Number 1105183052

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

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The device has been returned.Once the investigation is complete a supplemental report will be submitted.The patients weight is not provided as it is not taken at the time of the appointment.The exact date was not provided.Is not applicable with the exception of lot number as the device is manufactured by prescription.Implant/explant date: is not applicable as the device is manufactured by prescription and is not implantable.

Event Description

It was reported that the tap-d device caused a reaction.The patient has no pre-existing conditions.The patient received the device on 10-4-19 and wore it well and comfortable.The patient noticed the reaction 10-14 days after use (exact date unknown).The patient stopped using the device after consulting with the provider.The patient was allergy tested.The patient is allergic to: sulfa, nickel sulfate hexahydrate 2.5%, methyl methacrylate.Mild allergy to n,n-dimethyl-p toluidine, hydroquinone, palladium chloride.Full allergy report sent to glidewell.The patient was treated with flonase and nasal sinus rinse.With regard to the care of the device: it is unknown.The device was not cleaned by the provider prior to handing the device to the patient.

Manufacturer Narrative

The 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.Erkodent review: suppliers (erkodent) reviewed the associated material lots and confirmed no manufacturing deviations or abnormalities.Lot#: e2mm11297 (erkodur) was manufactured from 5/2019 and was assigned with 3 years expiration.Lot#: ep2mm11298 (erkoloc-pro) was manufactured from 5/2019 and was assigned with 3 years expiration.Airway management review: supplier (airway management) reviewed c of c analysis and confirmed chemical compositions are in compliance.Tracing the bonding material lots and found the lot numbers listed below, acrylic lot#: acr0750917, monomer lot#: monid3980.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 reviewed the returned parts including an upper tray, a lower tray in a tap case.The results were summarized below.Roughness - the edges of the appliance (both upper/lower) were smooth.Crack - no crack was found.Delamination - the layers were intact and did not appear separated.Discoloration - no discoloration was observed.General cleanliness - very clean and no white deposits or cell debris present with the device.Accessories - all accessories were inspected.Hook, locking screw, adjustment screw, bite pad and metal plate were all intact.Root cause: dream tap contained chromium content (20-30%) and is very possible to develop an allergic reaction in people with existing sensitivity.In this case, the patient was not reported having allergic to the chromium.However, the patient was reported strongly allergic to methyl methacrylate.Reviewing msds from monomer lot#: monid3980 confirmed the bonding material used for the reported device contained methyl methacrylate.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.Discontinue use if you are experiencing nausea, vomiting, soreness or an allergic reaction." however, the appliance was inspected and confirmed the device has no defect or abnormalities.Per "warnings and possible side effects" section from patient instruction for use sent to the patient, it contains the following statement, "allergic reaction may be encountered.Discontinue use if reaction occurs and consult prescriber." 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 article was thermoformed with layers of erkodent material (erkoloc-pro and erkodur).The test results were listed below and summarized in biocompatibility report for haley sleep device (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 tray materials (erkoloc-pro and erkodur) have been found to be biocompatible through the testing.

• Brand Name: TAP-D
• Type of Device: DREAM TAP
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine, ca
• MDR Report Key: 10438666
• MDR Text Key: 204014759
• Report Number: 3011649314-2020-00620
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K061732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1105183052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR