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

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

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned.An investigation will be conducted once the sample has been returned and a supplemental report will be submitted.Wight: 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 (date unknown) after wearing a dream tap device.The patient's gums were turning white and it felt like a second-degree burn.The patient later called the doctor stating, she was not sure if the dream tap device had caused the allergic reaction as she might have used some chemical to clean the device.The patient has no known allergies.

Manufacturer Narrative

The device has not been returned.However, 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# e2mm11307 (erkodur) was manufactured from 7/1/2019 and was assigned with 3 years expiration.Lot# e2mm11298 (erkoloc-pro) was manufactured from 5/20/2019 and was assigned with 3 years expiration.Airway management review: supplier (airway management) reviewed c of c analysis and confirmed material compositions are within specification.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results the device was not returned for investigation.Root cause: the root cause cannot be explicitly determined.Airway management confirmed the dreamtap has chromium content (20-30%) and is very possible to develop an allergic reaction in people with existing sensitivity.However, patient was reported having no known allergy in this case.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." 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." in addition, it was reported the patient cleaned the device with chemical (unknown), which was not recommended in patient instruction for use.Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device (haley) 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 haley 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.

• 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: 9735258
• MDR Text Key: 190487606
• Report Number: 3011649314-2020-00481
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR