|
Catalog Number 00856379007023 |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problem
Hypersensitivity/Allergic reaction (1907)
|
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
In this event it is reported that patient using non-template aligner arch for treatment experienced allergic reaction.Their symptoms included, rash, swelling of the throat and difficulty swallowing.It is reported that the patient has a number of known allergies including plastic, that they were also using a name brand appliance cleaner that may have also caused or contributed to the reaction.Their symptoms resolved on their own immediately after discontinuing aliger treatment.
|
|
Manufacturer Narrative
|
Dhr evaluation: we reviewed the dhr for this so-sr03835463 / patient id# j6y8 / practice id# (b)(4), qty.(b)(4) items assy-500011 (aligners), were packaged by of first shift by bag and box operation on (b)(6) 2024, manufacturing supercell sc1, equipment pua-07.The sales order was inspected and met with the acceptance criteria provided by qa.Photo investigation.The evidence provided by the customer does not specify suffering from allergies to the material and/or raw material used during the manufacturing process of the sure smile aligners.Failure mode: allergic reaction.Root cause: no defect proven.Conclusion code: no failure found.
|
|
Search Alerts/Recalls
|
|
|