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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. COMFORT HARD-SOFT SPLINT-UPPER; THERMOFORM MOUTHGUARD

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PRISMATIK DENTALCRAFT, INC. COMFORT HARD-SOFT SPLINT-UPPER; THERMOFORM MOUTHGUARD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 07/15/2021
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.
 
Event Description
It was reported that the patient had a reaction to the comfort hard-soft splint.It was reported that the patient had swollen lymph nodes, extreme fatigue, and brain fog.The patient initial use of the device was (b)(6) 2021 and noticed the reaction (b)(6) 2021 and progressively got worse.The patient discontinued usage of the device on (b)(6) 2021.Once discontinuation, the reaction lasted about a week.The patient did not receive any medical treatment.There is no medical history noted and has no known allergies.The patient current status is not as "feeling back to normal." with regard to the device: the provider noted that the device was cleaned but was not specific.The patient rinsed with mild soap, water and cleaned with toothbrush.
 
Manufacturer Narrative
The device has not been returned.However, the non-visual device 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) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Lot# e-pro 4.0-11615 (erkoloc-pro) was manufactured from april 16, 2021 and was assigned an expiration of april 2024 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.There have been attempts to establish communication with the provider but there has been no response.However, the non-visual device investigation has been completed.Root cause: a root cause for this complaint cannot be explicitly determined.Ifu 9091 rev 4.0 (comfort h/s bite splint instruction for use) states "brush and floss your teeth before use.Rinse mouth well with clean water before inserting the device.If patient uses mouthwash, all traces of mouthwash should be removed by thoroughly rinsing out mouth with water.Rinse bite splint well with clean, cool water before and after use.Clean bite splint with clean, cool water only and let air dry." ifu provides warning "do not clean or soak in mouthwash; do not use denture cleanser, hot water, alcohol, hydrogen peroxide; do not place in direct sunlight".It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.Per the reported information, the customer rinsed with mild soap, water and cleaned with toothbrush.Supplier erkodent reviewed the incident details and determined an allergic reaction cannot be ruled out.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 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 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 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.
 
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Brand Name
COMFORT HARD-SOFT SPLINT-UPPER
Type of Device
THERMOFORM MOUTHGUARD
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 Key12531982
MDR Text Key273302444
Report Number3011649314-2021-00328
Device Sequence Number1
Product Code MQC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 03/22/2022
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/30/2021
Initial Date FDA Received09/27/2021
Supplement Dates Manufacturer Received02/23/2022
Supplement Dates FDA Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age52 YR
Patient SexFemale
Patient Weight66 KG
Patient RaceWhite
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