(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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, weight, bmi at the time of index procedure.Name of initial surgical procedure.The diagnosis and indication for the initial surgical procedure? 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? when was current urethral pain occurred? character of pain? what medical intervention was given for the pain management? results? was the cystoscopy performed already? results? is the device planned to be removed or removed already? if so, please provide a date and details of the re-operation.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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