Catalog Number 00856379007023 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 10/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
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Event Description
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In this event it is reported that patient experienced allergic reaction to the use of non-template aligner arch.Patient experienced burning sensation on the tongue and lips.When they leave out the aligners they do not get these symptoms.
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Manufacturer Narrative
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Investigation: dhr evaluation: we reviewed the dhr for this (b)(4) / patient id# (b)(6)/ practice id# (b)(6) qty.(b)(4) items assy-500011 (aligners), were packaged by of first shift by bag and box operation on (b)(4) 2023, manufacturing cell 6, equipment bag-13.The sales order was inspected and met with the acceptance criteria provided by qa.Failure mode: allergic reaction.Root cause: no defect.Conclusion code: no failure found.
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Search Alerts/Recalls
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