MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT INC. DREAM TAP

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

Patient Problems Erythema (1840); Swelling (2091)

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.Patient weight: asked, but unknown.Date of event: asked, but unknown.Model number: not applicable.Catalog number: not applicable.Lot number: not applicable.Udi: not available.Initial reporter: not available.

Event Description

It was reported that a patient experienced an allergic reaction after using a dream tap appliance.According to the information provided by the doctor, the patient experienced redness and swelling of her lips and gum tissue, where they came in contact with the device.The patient didn't notice the reaction right away and is not sure if appliance is what is causing the reaction.It is unknown whether or not the patient has any known allergies.The patient has the sample with her and it is unknown if such a sample is being returned.

Manufacturer Narrative

The device was available for evaluation.A batch/lot review for the associated material showed no manufacturing deviations or abnormalities.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: 9444856
• MDR Text Key: 170251342
• Report Number: 3011649314-2019-00763
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR