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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); 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.Patient ethnicity and race: 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.The serial number 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 a red and irritated tongue.The device was worn for a few days and the symptoms have not gone away as of (b)(6) 2022.The patient has been advised to seek the advise of an allergist for a more definitive results.

Event Description

Update: the device was issued on (b)(6) 2022 and used that evening.The patient called the provider on (b)(6) 2022 with complaints of a "burning tongue." it is believed that reaction occurred prior to the date the patient called in.The device was discontinued on 11-28-2022 and the symptoms resolved within a week.The current status is noted as "healthy." there are no known allergies and no medical history noted.With regards to the device: the device was rinsed with warm water and a brush type unknown).

Manufacturer Narrative

Additional information: this complaint will be kept on record for tracking and trending purposes.

Manufacturer Narrative

The device was returned, the investigation 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 ones known from gl.Erkodent review: lot# erkodur e2mm11819205 (erkodent) was manufactured from feb.14, 2022 and was assigned an expiration of feb.2022.Lot# e-pro ep2mm11841203 (erkodent-pro) was manufactured from march 22, 2022 and was assigned an expiration of march 2022.Supplier (airway management) no deviation.C of c analysis shows material compositions are within specification.Airway management review: part #: 12k-osha-22 was manufactured on september 26, 2022 and no expiration date was noted.Kit #: pkt12k-osnl-22 was manufactured on june 13, 2022 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: complaint investigator visually inspected the returned device.The returned device was visually inspected and no defect or abnormality was observed.There was no evidence found to indicate that the reported issue was caused by the device itself.The returned parts included both upper and lower with case.The results were summarized: roughness - the flange was smooth; internal/external surfaces were smooth.Delamination - layers were intact and did not separate.Discoloration - the device appeared clear hint of yellow and transparent.General cleanliness - the returned device appeared to be clean, free of debris or foreign particles.Root cause: a root cause for this complaint cannot be explicitly determined.Per the reported complaint, "is experiencing red tongue, irritated." it is possible it is caused by the material.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.

Manufacturer Narrative

Capa 23-006.Manufacturer reference: (b)(4).

• 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: 16140167
• MDR Text Key: 307117203
• Report Number: 3011649314-2022-00761
• 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,Followup,Followup
• Report Date: 05/22/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 04/19/2023; 05/02/2023; 04/26/2024
• Supplement Dates FDA Received: 04/25/2023; 05/15/2023; 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 165 KG
• Patient Race: White