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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Irritation (1941); Swelling (2091); Reaction (2414)
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Event Date 04/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Date of event was asked, and it was advised to be some time in (b)(6) 2019.Request was made to have the reported nightguard return for evaluation; however, the nightguard has not been returned as of late.Once the evaluation is completed, a supplemental report will be submitted.This report is for the 3rd of 3 reported events: please reference 3011649314-2019-00162 ((b)(4)) for the 1st event.Please reference 3011649314-2019-00169 ((b)(4)) for the 2nd event.
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Event Description
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This report is for the 3rd event: after the patient resumed use of a silent night nightguard, it was reported that "once again same symptoms occurred, only this time my lips were slightly inflamed, same irritation at the corners of my mouth, my tongue started looking very fissured and red.My gums got really red and puffy/inflamed and i felt that i had a funny film (or sensation of film) in my mouth." the reaction continued for the entire time the patient wore the appliance (approx.1 week).The patient reported that they stopped everything and it gradually went away.The patient did not require any treatment for the reaction.The patient was reported to be doing better now.The patient has history of hodgkin's lymphoma (treated with chemo and radiation) and currently taking levothyroxine.The patient also has penicillin and brazil nuts allergies.No adjustment was made to the nightguard.The nightguard was cleaned using only water and toothbrush.No disinfectant was used.
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Manufacturer Narrative
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The xtra silent nite was manufactured per patient's prescription (rx) and returned for analysis.A visual inspection was performed on the returned device.The edge was smooth and no major cracks were found.The device's layers were intact and did not separate.The device was very clean with no discoloration observed.Both connectors were intact.The device and case were returned in a good condition with the original label.A batch/lot review for the associated material showed no manufacturing deviations or abnormalities.Glidewell research team and namsa conducted a series of testing on erkodent material (erkoloc-pro and erkodur) 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 results were listed and summarized in 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 test.· 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.This complaint will be kept on record for track and trending purposes.
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Search Alerts/Recalls
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