Date sent to the fda: (b)(6) 2023.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This event was previously submitted under ethicon mdr summary reporting exemption e2013037.Initial psr reporting period: (b)(6) 2016, through (b)(6) 2016.Psr submission number: 2210968-2016-33270; psr report identifier: 2210968-2016-34342; all event details will now be captured via emdr report number 2210968-2023-06087.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, 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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It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2007, and mesh was implanted.It was reported that following insertion the patient experienced burning, infection, and urinary retention.No additional information was provided.
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