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Lot Number E-PRO 4.0-11770201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Type
Injury
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Event Description
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It was reported that the patient had a reaction to the that was issued.The device was issued on (b)(6) 2022 and used that evening.It is unclear when the reaction occurred.However, the device was discontinued on (b)(6) 2022 and it is unclear when it resolved.The patient has allergies to numerous materials that are in rubber.
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Manufacturer Narrative
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The device has been returned.Once the investigation is complete a supplemental report will be submitted.
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Manufacturer Narrative
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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) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.Lot# e-pro 4.0-11770201 (erkoloc-pro) was manufactured from november 17, 2021 and was assigned an expiration of november 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: complaint investigator reviewed the returned device.An upper splint was returned in the original case.The results were summarized: roughness - the flange was smooth; internal/external surfaces were smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device turned yellowish due to the usage.General cleanliness - the returned device was not clean and debris can be observed.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.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: use only clear, cool water to wash the device.Do not clean or soak in mouthwash.Do not use denture cleanser.Do not use hot water.Do not use alcohol or hydrogen peroxide.Do not place in direct sunlight.Keep away from heat sources." it is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.However, the customer did not provide the information regarding how the patient handled and maintained the device.Supplier erkodent reviewed the incident details and determined it was an unclear case.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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Manufacturer Narrative
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Additional data: b2, d4, h4, h6 (type of investigation code, and investigation conclusions code).Corrected data: h6 (health effect - impact code).Device labeling: use of the device may cause: tooth movement or changes in dental occlusion, gingival ordental soreness, obstruction of oral breathing, pain or soreness to the temporomandibular joint, excessive salivation.Regular dental follow-ups are recommended to review any side effects to avoid device breakage, allergic reaction, irritation, or discomfort that leads to frustration or discontinuation of this therapy.Capa: 23-006.Manufacturer reference: (b)(4).
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Search Alerts/Recalls
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