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

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/28/2021

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.The patients weight is not taken at the time of the appointment.Is not applicable with the exception of serial number as the device is manufactured by prescription.Is not applicable as the device is manufactured by prescription and not implantable.

Event Description

It was reported that the patient experienced a reaction to the tap iii.Patient experienced "redness and bumpiness on inside of lower lip, itchy, and tip of tongue.The device was delivered (b)(6) 2021 and used that evening.The reaction was noticed (b)(6) 2021.The patient wore the appliance until (b)(6) 2021 with the reaction resolving 5 days later.The patient was prescribed magic mouthwash, and the current status is noted as "back to normal." the patient has allergies to sulfa and nickel and other "cheap metals." there is a history of insulin dependent diabetes (iddm).With regards to the device, it is unknown if the device was cleaned prior to delivery, it is also unknown how the patient cared for the device.

Manufacturer Narrative

The device has not been returned.However, the non-visual device evaluation has been completed and the results are as follows: dhr results: the dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results: customer stated the device has been requested for return but to date has not been received.However, the non-visual device investigation has been completed.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 the reported information, the patient has allergies to sulfa, nickel, and other "cheap metals." additionally, the customer did not provide the information regarding how the patient handled and maintained the device.Per tap3 patient instruction_prtd17 rev.I, the "home care instructions" section states the following: "each morning after use, thoroughly clean your tap¿ 3 appliance using a regular soft toothbrush, cool water and toothpaste.The tap¿ 3 should be stored in a cool dry place.The appliance is made from sensitive materials and should not be stored where temperatures exceed 120of, such as in the glove compartment of a car or the cargo hold of an airplane.Do not clean the appliance in hot or boiling water, nor to soak it in bleach or hydrogen peroxide which will cause the trays to distort or the lining to become brittle and delaminate." per tap3 patient instruction_prtd17 rev.I, the "warnings" section states the following: "patients who are sensitive to nickel or self-curing acrylic may experience allergic reactions.Per tap3 patient instruction_prtd17 rev.I, the "warnings" section states the following: the metal parts are made of medical grade stainless steel or cobalt chromium.If the patient experiences any reaction, have him/her contact the prescriber immediately.Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device (haley) 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.Supplier's (erkodent & airway management) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Additionally, erkodent reported no further complaints for this material lot.Erkodent review: lot# erkodur 2.0-11693 (erkodur) was manufactured from august 16, 2021 and was assigned an expiration of august 2024.Lot# e-pro 2.0-11336 (erkoloc-pro) was manufactured from october 21, 2019 and was assigned an expiration of october 2024.Airway management review: part #: 12k-0qzv-21 was manufactured on 06/03/2021 and no expiration date was noted.Kit #: pkt12k-0qzt-21 was manufactured on 06/03/2021 and no expiration date was noted.Supplier (airway management) reviewed c of c (certificate of conformance), a chemical analysis report, and confirmed material compositions are within specification.

• Brand Name: TAP III
• Type of Device: TAP III
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer Contact: herbert crane ; 2144 michelson drive; irvine, CA 92612 ; 9495021907
• MDR Report Key: 13022781
• MDR Text Key: 284732948
• Report Number: 3011649314-2021-00482
• 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: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2021
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Race: White