(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? the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? 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 the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? describe any medical/surgical intervention 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? a manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Product complaint#: (b)(4).Date sent to fda: 04/28/2021.Additional information was requested and the following was obtained: 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? 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 the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? describe any medical/surgical intervention 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? yes, they said it was bulging and causing irritation.No, info on patient or any further details unfortunately.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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