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 mild allergic reaction to nontemplate aligner arch.Patient's symptoms included gum irritation and itching.The dentist has not recommended discontinuation of aligner therapy at this time.No known additional medical intervention has required to date.
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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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Manufacturer Narrative
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Dhr evaluation: we reviewed the dhr for this (b)(6) / patient id# (b)(6) / practice id# (b)(6) qty.60 items assy-500011 (aligners), 6 items assy-500010 (template) were packaged by of first shift by auto packing operation on (b)(6) 2023, manufacturing supercell sc1, equipment pua-07.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: (b)(6) 2023.· the material was found to be acceptable for use in the manufacture of the sure smile product.
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Search Alerts/Recalls
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