Product complaint # (b)(4).
Component code: (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.
This file was reviewed by a cross functional team during the weekly ae review and the following questions were requested and assigned to bq via pcf: the patient demographic info: age, weight, bmi at the time of index procedure date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? 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? was the exposed mesh excised? describe any medical/surgical intervention for exposure and stones including dates and surgical findings.
Product code and lot # what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.
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