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 01/17/2024 |
Event Type
Injury
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Event Description
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In this event it is reported that patient experienced allergic reaction to the nontemplate aligner arch.The patient developed irritation in the form of blisters around the trimline of the aligners and their asthma worsened when wearing the aligners.The patient stopped wearing the aligners and left the doctor office know.The doctor had the patient retry the aligners and the patient had the same reaction to the wearing of the aligners.Aligner treatment was stopped.
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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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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Manufacturer Narrative
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Dhr evaluation: we reviewed the dhr for this so-(b)(6) / patient id# (b)(6) / practice id# (b)(6) qty.(b)(4) items assy-500011 (aligners) (b)(4) item assy-500010 (template), were packaged by of first second by bag and box operation on (b)(6) 2023, manufacturing supercell sc0, equipment bag-15.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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