(b)(4).Attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure.The diagnosis and indication for the index surgical procedure? what skin prep was used pre-op? what were current symptoms following the index surgical procedure? onset date? were there any pre-existing signs /symptoms of active infection prior to the surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra-op? were cultures performed? results? what medical intervention was performed for the patient? results? other relevant patient history/concomitant medications.Product code and lot #.If applicable, will product be returned, return date, tracking information.What is physician¿s opinion as to the etiology of or contributing factors to this event.What is the patient¿s current status?.
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