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

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

Patient Problems Pain (1994); Rash (2033); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The patients weight is not provided as it is not taken at the time of the appointment.Exact date of event was not provided when asked.Not applicable for this device with the exception of the lot number and the operator of the device.The device has not been returned.If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.This is the second of two implant complaints, see manufacturer report for the remaining complaint: 3011649314-2020-00471 ((b)(4)).

Event Description

It was reported that the patient had a possible allergic reaction after using tap 3 sleep device.The provider notes that the patient received the device on (b)(6) 2019 and shortly thereafter developed rash noting the location as "intraoral and lingual center of lips." the provider states that the patient was not allergy tested prior to the delivery of the device.He further states that the patient was provided care instructions: "wash with warm water and soap and leave to air dry." the provider notes the patient saw the primary care provider and was given antibiotics (unknown medication).The primary care provider instructed the patient to stop using the device and try again after a couple of days.The patient again experienced a painful rash on the lingual tissue portion of the lips.The provider states, "the patient may consider taking an allergy test.".

Manufacturer Narrative

The device was not returned, but did not transfer to the investigator.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# e2mm11297 (erkodur) was manufactured from 5/5/2019 and was assigned with 3 years expiration.Lot# ep2mm11298 (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 (see attached email).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 returned but it was not available for investigation.See note in additional information.Root cause 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." glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device 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.The sleep device materials (erkoloc-pro and erkodur) have been found to be biocompatible through the testing.There was no cytotoxic, sensitization, skin irritation, or oral mucosal irritation found in any of the test articles.

• Brand Name: TAP III
• Type of Device: TAP III
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine, ca
• MDR Report Key: 9728465
• MDR Text Key: 190486306
• Report Number: 3011649314-2020-00472
• 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: 06/19/2020

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: 01/22/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 05/18/2020
• Supplement Dates FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR