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

Lot Number 1020224682

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

Patient Problems Burning Sensation (2146); Tingling (2171)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

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 section is not applicable (with the exception of the lot number) as this device is manufactured by prescription.

Event Description

It was reported that the patient had a reaction to the tap3 device.This was not a remake device.The patient has allergies to: pine trees, penicillin, and iodine contrast dye.The patient also has a history of pre-diabetic syndrome and hypertension.The current medication regime is metformin, diavan, baby aspirin.The device was delivered to the patient on (b)(6) 2020 and was used for the first time on (b)(6) 2020.The patient noticed the reaction on (b)(6) 2020.The patient noted, "lips cherry red and tingled, went beyond lip line, mainly upper lip, only a little on the lower lip, over 3 weeks for the upper lip, tightness and tingling." the patient did not require medical treatment.(used chapstick for comfort) the patient discontinued the use of the device and the symptoms subsided after two weeks.With regard to the care of the device.The device was cleaned prior to issuance of the device.The patient was provided cleaning instructions: clean with water and toothpaste and brush with toothbrush.The device has not been returned.They are waiting on a dream tap to be delivered.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: 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# e2mm11307(erkodur) was manufactured from 7/1/2019 and was assigned with 3 years expiration.Lot# ep2mm11298 (erkoloc-pro) was manufactured from 5/20/2019 and was assigned with 3 years expiration.Erkodent has no further complaints about these lots.Airway management review: supplier (airway management) reviewed c of c analysis and confirmed material compositions are within specifications.Stock product reviewed results: no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results: complaint investigator visually inspected the returned device.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 smooth.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 - overall was 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 airway management confirmed the tapiii has nickel content (3-5%) and is very possible to develop an allergic reaction in people with existing sensitivity.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.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 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,
• MDR Report Key: 10112489
• MDR Text Key: 194946982
• Report Number: 3011649314-2020-00533
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1020224682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 79