Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Additional information in h6: component, investigation type, findings, and conclusions.Inspection the device was not returned and no photos were provided, so an evaluation is unable to be performed.Dhr review: the device was not returned and the lot number was not reported, therefore a dhr is unable to be located for review.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown surgical or patient factors.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.Reference report 3004788213-2023-00113.
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