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Catalog Number SPMII |
Device Problem
Migration (4003)
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Patient Problems
Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120)
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Event Type
Injury
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Manufacturer Narrative
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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.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.
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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) 2012 and two (2) mesh products were implanted, due to pelvic organ prolapse and urinary incontinence.It was reported that the patient experienced recurrent urinary incontinence, vaginal bleeding, inflamed cervix, recurrent urinary tract infections, dyspareunia, chronic pain, foul smelling discharge, erosion of the mesh into her vaginal wall, and erosion of the other mesh into her cervix and adherence to her bowel.It was reported that the patient underwent surgical procedures on (b)(6) 2019 and (b)(6) 2020 to remove the products.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 06/08/2023.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: 3/12/2024.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: 3/26/2024.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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