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Catalog Number 00856379007023 |
Device Problem
Patient-Device Incompatibility (2682)
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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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In this event it is reported that a patient experienced an allergic reaction to nontemplate aligner arch after initial use.Reportedly, the patient had symptoms of nausea, burning sensation in the mouth, migraine headache and insomnia.Aligner therapy was discontinued about 1 month after symptoms onset; however, symptoms have not yet resolved.No known additional medical intervention has required to date.The patient does not have any known allergies.
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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.Investigation development:the investigation is based in the manufacturing process of aligners, retainers, templates.Dhr evaluation: we reviewed the dhr for this (b)(4)/ patient id# (b)(6)/ practice id# (b)(4), qty.(b)(4) items assy-500011 (aligners) (b)(4) items assy-500010 (templates), were packaged by of first shift 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.We reviewed the incoming inspection record for the material used to manufacture this (b)(4).Raw material: part-501019 / lot# 231446 / qty.Received = (b)(4) rolls, inspection date: may 17, 2023.The material was found to be acceptable for use in the manufacture of the sure smile product.After reviewing the records generated during the manufacturing process (dhr).We found no failure in the manufacturing process.
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Manufacturer Narrative
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Investigation other: very easy treatment, all the movements are done according to the groupings.Nothing outside the dl protocols.Investigation dhr: dhr evaluation: we reviewed the dhr for this (b)(6) / patient id# (b)(6) / practice id# (b)(6) qty.(b)(4) items assy-500011 (aligners) 2 items assy-500010 (templates), were packaged by of first shift by bag and box operation on september 1, 2023, manufacturing supercell sc0, equipment bag-15.The sales order was inspected and met with the acceptance criteria provided by qa.Incoming inspection.We reviewed the incoming inspection record for the material used to manufacture this (b)(6).Raw material: part-501019 / lot# 231446 / qty.Received = 300 rolls, inspection date: may 17, 2023.The material was found to be acceptable for use in the manufacture of the sure smile product.Failure mode: allergic reaction.Root cause: no defect proven - no defect proven during manufacturing process.Conclusion code: no failure found.
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Search Alerts/Recalls
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