Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the 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 initial surgical procedure.The diagnosis and indication for the initial surgical procedure? product code and lot #.Other relevant patient history/concomitant medications.The initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? mesh exposure site/location? describe any medical/surgical intervention for exposure including dates and surgical findings.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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