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.Reference reports 3012447612-2017-00463, 3012447612-2017-00464, 3012447612-2017-00465, 3012447612-2017-00496, and 3012447612-2017-00497.
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