MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. TAP III; ANTI-SNORING DEVICE, TAP III

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

Patient Problems Burning Sensation (2146); Reaction (2414)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation yet.Once the evaluation is completed, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced an allergic reaction using the tap iii device.The patient complained of burning sensation and bumps on the tongue and on the area that touched the appliance.These symptoms went away 6 days after the patient stopped using the appliance.No treatment was given for the reaction.The symptoms already went away when the patient visited the clinic.The patient has no relevant pre-existing condition; however, the patient may have metal allergy (not specified what metal) according to the dentist.The dentist did not make any adjustment to the appliance prior delivering to the patient.The patient was recommended to clean the appliance using warm water.The patient was reported to be doing ok and having no issue with the dreamtap.

Manufacturer Narrative

The reported device was not available for an evaluation.Without the device, physical structure testing cannot be completed; however, tests were performed on a similar device.The reported mouthguard was fabricated per physician's prescription request.A review of the material lot was performed and no non-conformity was found.A series of biocompatibility tests were performed on a similar thermoformed mouthguard.It was found that the sleep device materials are biocompatible.Cytotoxicity test was completed on the test article and there was no evidence of toxicity nor cell lysis.There was no evidence of erythema and no edema observed for skin irritation test.Sensitization test showed no evidence of the test article causing delay dermal contact nor oral mucosal irritation.Although the root cause for the allergic reaction could not be explicitly determined, a probable cause could be an allergy to the metal.Per the provided information, it was reported that the patient might have metal allergies.While the appliance hardware has a very low nickel composition (3-5%), there is a possibility of developing an allergic reaction in people with existing sensitivity.In this case, the patient might have a pre-existing allergy to metal.There were no device problems found.This incident is being monitored, tracked, and trended.

• Brand Name: TAP III
• Type of Device: ANTI-SNORING DEVICE, TAP III
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• Manufacturer Contact: toan hoang ; 2212 dupont drive; suite p; irvine, CA 92612 ; 9492251235
• MDR Report Key: 7603904
• MDR Text Key: 111135982
• Report Number: 3011649314-2018-00185
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR