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

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If/when there is more information provided, a supplemental report will be submitted.The patients date of birth was not provided when asked.The patients weight is not provided when asked.This information not provided when asked.Date of event: this information was not provided when asked.Relevant tests/laboratory data and other relevant history: this information was not provided when asked.Device information: is not applicable with the exception of serial number as the device is manufactured by prescription.The device is manufactured by prescription and not implantable.

Event Description

It was reported that the patient had a reaction to the tap iii that was issued.It is unclear when the patient received the device, when the patient first used the device, or when the reaction occurred or resolved.However, it is noted that the patient experienced swollen lips.

Manufacturer Narrative

The device was not 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.Supplier (erkodent) the retained samples from both lots were reviewed.No manufacturing deviations or abnormalities are known.We have no further complaints except the known ones from gl erkodent review: lot# erkodur e2mm11791202 (erkodent) was manufactured from january 10, 2022 and was assigned an expiration of january 2025.Lot# e-pro ep2mm11764112 (erkodent-pro) was manufactured from november 04, 2021 and was assigned an expiration of november 2024.Supplier (airway management) no deviation.C of c (certificate of conformance) analysis, shows material compositions are within specification.Airway management review: part #: dr75-orng-21 was manufactured on november 16, 2021 and no expiration date was noted.Kit #: 22 pkt75k-ornt-21 was manufactured on november 16, 2021 and no expiration date was noted.Garreco acrylic review: supplier reviewed c of a (certificate of analysis), a chemical analysis report, and confirmed material compositions are within specification.Sandvik osprey monomer review: supplier reviewed c of a (certificate of analysis), a chemical analysis report, and confirmed material compositions are within specification.Stock product reviewed results: no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results: no device has been returned from the customer.However, the non-visual device investigation has been completed.Root cause: a root cause for this complaint cannot be explicitly determined.Per tap3 patient instruction_prtd17 rev.I, the "home care instructions" section states the following: rinse with water before use.Always brush your teeth and floss well before inserting the tap¿ 3 in your mouth.Each morning after use, thoroughly clean your tap¿ 3 appliance using a regular soft toothbrush, cool water and toothpaste.Hot water should not be used.Rinse thoroughly after cleaning and dry the appliance completely before storing in the container.It may help to leave the container open to ensure that the tap¿ 3 dries thoroughly.Per tap3 patient instruction_prtd17 rev.I, warning: 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, warning: do not dissemble any of the tap¿ 3 hardware.The tap¿ 3 is a medical device and the patient must not tamper with it other than following specific instructions in the patient instruction booklet.This complaint will be kept on record for tracking and trending purposes.

• 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: 15820345
• MDR Text Key: 303906432
• Report Number: 3011649314-2022-00619
• 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: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• 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: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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 Sex: Female