MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. DREAMTAP

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

Patient Problems Itching Sensation (1943); Rash (2033); Tingling (2171); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Multiple follow-ups were conducted to obtain additional information and device for evaluation; however, the office has not provided event information or returned device back for evaluation.Once the evaluation of the event is completed or new information is obtained, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced an allergic reaction after using the dreamtap nightguard.The patient complained of itching and dry mouth.The patient also had rash on lips and "a tingling feeling".The patient has known chromium allergy.

Manufacturer Narrative

The device was manufactured per patient's prescription (rx) and returned for an analysis.A visual inspection was performed on the returned device.The edges of the device were very smooth.No major cracks were found and the layers were intact.The original color was maintained without discoloration.The device was returned very clean and in good condition.There was no white deposits or cell debris present with the device.All accessories were inspected and were confirmed to be intact.A review of the material lot was performed and no non-conformance's were found.A series of testing were performed on a similar device.The device (model variant) was evaluated for cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The test article showed no evidence of causing cell lysis or toxicity.There was no erythema nor edema observed.There was no evidence of the device causing delayed dermal contact sensitization, nor oral mucosal irritation.There were no device problems found with the test article.However based on the reported information, the patient has a known chromium allergy.The device contains chromium (20-30%); therefore, basing on patient factors, there is a possibility that the patient's reaction occurred due to their sensitivity/allergy to chromium.This incident is being monitored, tracked, and trended.

• Brand Name: DREAMTAP
• Type of Device: DREAMTAP
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 8368657
• MDR Text Key: 137113523
• Report Number: 3011649314-2019-00019
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• 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: 03/06/2019
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other