Date of event: the exact date of the event was not reported.The lot information is unknown therefore a lot number device history record and ship history review to identify potential lot could not be conducted.The subject device was not received for investigation; therefore, no physical or visual analysis of the product could be performed.Based on review of the information available, pain is known risk associated with the use of the device and is noted as such in the instruction for use (ifu).An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
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