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.Device evaluation: product not returned, photos not provided and x-rays not provided.Device evaluation unable to be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to operational factors, patient factors, or post-op care factors.Dhr review: dhr unable to be reviewed as lot number is not known.Device use: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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