MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT INC. DREAM TAP

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

Patient Problem Erythema (1840)

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned.An investigation will be conducted once the device/sample has been returned and a supplemental report will be submitted.Weight: asked, but unknown.Date of event: asked, but unknown./model number: not applicable.Catalog number: not applicable.Lot number: not applicable.Expiration date: not applicable.Udi number: not available.

Event Description

It was reported that a patient experienced an allergic reaction 3 months (date unknown) after wearing a dream tap nightguard.The patient had red patches on the cheeks.The patient has no known allergies.

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.Returned sample: complaint investigator reviewed the returned parts with production on 1/22/20 the returned parts included an upper tray, a lower tray, and an adjustment key 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 - the device turned yellowish due to the normal usage.General cleanliness - very clean and no white deposits or cell debris present with the device.Accessories - all accessories were inspected.Hook, adjustment key, locking screw, adjustment screw, bite pad and metal plate were all intact.Root cause: a root cause for this complaint cannot be explicitly determined.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." it was unknown how patient was instructed to handle and maintain the device.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 erkodent material (erkoloc-pro and erkodur) 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 and summarized in 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 test.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.This complaint will be kept on record for track and trending purposes.

• Brand Name: DREAM TAP
• Type of Device: DREAM TAP
• Manufacturer (Section D): PRISMATIK DENTALCRAFT INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 9194324
• MDR Text Key: 162381262
• Report Number: 3011649314-2019-00590
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• 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: 01/14/2020
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR