Method: a device was received for analysis of the same lot number and model.A visual inspection was performed and a review of the device history record was conducted for the lot number reported.Results: at this time, the evaluation is still in progress.Results will be provided once completed.Per the dhr review there were no reworks, special conditions, or related nonconformance reports (ncrs) for this reported lot number.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusions: once the investigation and device analysis are completed a follow-up report will be submitted.Information from this incident will be included in our product complaint and mdr trend reporting system.Additional investigation may arise from ongoing analysis, trend information, or other analysis as appropriate.
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