MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT INC. TAP III

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

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned.An investigation will be completed once the sample has been returned and a supplemental report will be submitted.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 after using a tap iii appliance.The specific allergic reaction is unknown as the doctor would not provide further details.The date of the allergic reaction is unknown as the doctor did not provide such date.It is unknown whether or not the patient has any 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 inspected: the returned parts included both upper and lower tray in a tap case.The results were summarized below: roughness - the edges of the appliance (both upper/lower) was not rough.Crack - no crack was found.Delamination - layers were intact and did not appear separated.Discoloration - color turned yellowish due to the normal usage.General cleanliness -not clean but some debris present with the device.Accessories - metal accessories were inspected.Hook, locking screw, adjustment screw, the bite pad, adjustment key and the metal plate were all intact.Root cause: per returned part visual inspection, the returned device had no defect and abnormalities.Airway management confirmed the tapiii has nickel content (3-5%) and is very possible to develop an allergic reaction in people with existing sensitivity.However, it was unknown patient was reported to be allergic due to the nickel.Per "warnings" section from patient instruction booklet sent to the patient, it contains the following statement, "allergic reaction may be encountered in people who are sensitive to nickel or self-curing acrylic." 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." the appliance was inspected and confirmed the device has no defect or abnormalities.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 articles showed no evidence of causing cell lysis or toxicity.This complaint will be kept on record for track and trending purposes.

• Brand Name: TAP III
• Type of Device: TAP III
• Manufacturer (Section D): PRISMATIK DENTALCRAFT INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 9074046
• MDR Text Key: 161056300
• Report Number: 3011649314-2019-00536
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K062951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• 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: 11/13/2019
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention