(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 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.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure in 2016? the diagnosis and indication for the index surgical procedure in 2017? were any concomitant procedures performed in 2016 or 2017? other relevant patient history/concomitant medications? what was the initial approach for the index surgical procedure in 2016? were any concurrent devices implanted in 2016 or 2017? were there any intra-operative complications in 2016 or 2017? when was the mesh exposure first noted by a physician? please provide the mesh exposure site/location, symptoms and diagnostic confirmation for the event in 2023.Describe any medical/surgical intervention for exposure including dates and findings.Were any deficiencies or anomalies noted with mesh device? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? 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.H6 component code: g07002 ¿ device not returned additional information: d4, h4 ¿ the actual device batch number associated with this event is not known.The following possible lot number was reported: 3822871 a manufacturing record evaluation was performed for the possible finished device lot, and no related non-conformances were identified.Related events captured via 2210968-2024-00009, 2210968-2024-00010, 2210968-2024-00011, 2210968-2024-00012, 2210968-2024-00013.
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