Product complaint # (b)(4).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, weight, bmi at the time of index procedure? date and name of initial surgical procedure? what are the patient comorbidities/concomitant medications? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? were there any concomitant procedures performed? when did the bleeding occur and what was the volume of blood loss? was any abnormality of the device noted prior to, during or after the procedure? describe any medical/surgical intervention for exposure, bleeding, and discharge including dates and surgical findings? product code and lot #? 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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