PRISMATIK DENTALCRAFT, INC. COMFORT HARD-SOFT BITE SPLINT; THERMOFORM MOUTHGUARD, COMFORT SPLINT
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Rash (2033); Reaction (2414)
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Event Date 02/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Patient's weight was asked but unknown.Date of event was asked; however, it was only known to be in (b)(6) 2019.Request was made to have the mouthguard back for evaluation; however, the mouthguard is currently in patient's possession.The office would ask for the mouthguard back.Once the evaluation is completed, a supplemental report will be submitted.
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Event Description
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It was reported that a patient experienced an allergic reaction using the comfort hard-soft bite splint.The patient reported to have redness and lesions around the mouth.The patient had been using the mouthguard for around 3 months.Upon experiencing the reaction, the patient stopped using the mouthguard and the symptoms went away in a few days.The patient did not require any treatment for the reaction.The patient was reported to be doing fine.The patient has no relevant medical or dental pre-existing condition or known allergies.The doctor did not make any adjustment to the mouthguard prior delivering to the patient.The patient cleaned the mouthguard using only water.
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Manufacturer Narrative
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The device was not returned for evaluation.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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