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Catalog Number TVTRL |
Device Problem
Migration (4003)
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Patient Problems
Abdominal Pain (1685); Erosion (1750); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Foreign Body In Patient (2687)
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Event Type
Injury
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Event Description
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It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2021 and mesh and mesh were implanted.It was reported that the patient experienced chronic pelvic, perineal, vaginal and abdominal pain that radiates from her back and tailbone down to her things and legs, dyspareunia, vaginal discharge, infections, abdominal bleeding, mesh erosion and scarring.It was reported that the patient underwent removal surgery on (b)(6) 2023 during which the pathology report showed foreign body giant cell reaction.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 4/3/2024.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.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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Manufacturer Narrative
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Date sent to the fda: 4/15/2024.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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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Search Alerts/Recalls
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