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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. XTRA SILENT NITE GUARD; THERMOFORM MOUTHGUARD

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PRISMATIK DENTALCRAFT, INC. XTRA SILENT NITE GUARD; THERMOFORM MOUTHGUARD Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
Event Description
It was reported that the patient had a reaction to the silent nite 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.
 
Manufacturer Narrative
The device has not been returned.If/when there is more information provided, a supplemental report will be submitted.Udi is not applicable with the exception of serial number as the device is manufactured by prescription.Implanted date is not applicable as the device is manufactured by prescription and not implantable.
 
Manufacturer Narrative
Capa 2023-006 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.Supplier (erkodent) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Lot# e-pro: 3mm11840204 (erkoloc-pro) was manufactured from march 21, 2022 and was assigned an expiration of march 2025.Lot#: 22145 (connectors) was manufactured from november 11, 2021 and was assigned an expiration november 2024.Lot#: 10m-oskv-22 (bite tabs) was manufactured from may 24, 2022 and was assigned an expiration of 1 year.Lot#: slcn l31eac2560 (hardware) was manufactured from september 1, 2022 and was assigned an expiration of august 31, 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 customer did not return the complaint part for investigation.However, the non-visual device investigation has been completed.Root cause a root cause for this complaint cannot be explicitly determined.Ifu 7322 rev 6.0 (silent nite sleep appliance instructions for use) provides warning in "precautions" section: · do not soak the device in mouthwash, denture cleanser, hot water (> 50 °c) or alcohol.· do not wash the device with soap, toothpaste, or mouthwash.· do not dry the device with a blow dryer.· do not store in direct sunlight." per the reported information, the patient has an allergy to latex.Supplier erkodent reviewed the incident details and stated "it is unusual that a real allergic reaction starts only after 8 days, it could have other causes." 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 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
XTRA SILENT NITE GUARD
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 Key15760185
MDR Text Key303336088
Report Number3011649314-2022-00603
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 11/29/2023
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 10/11/2022
Initial Date FDA Received11/09/2022
Supplement Dates Manufacturer Received06/13/2023
Supplement Dates FDA Received11/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/29/2022
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 SexMale
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