Catalog Number TVTS4 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Erosion (1750); Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).Total number of events ¿ (b)(4).Gynecare tvt secur system.
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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) 2010 and the mesh was implanted due to urinary incontinence and cystocele.Following the procedure, the patient experienced pain and erosion and underwent multiple surgeries and re-visionary procedures.No further information is available.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).Reporting period (b)(6) 2016.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Date sent to the fda: 06/28/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.
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Manufacturer Narrative
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Date sent to the fda: 08/29/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.
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Manufacturer Narrative
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Date sent to fda: 04/12/2018.Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2016 through (b)(4), 2016.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4) reporting period october 1, 2016 through november 30, 2016.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.
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Manufacturer Narrative
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Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037
reporting period (b)(4) 2016 through (b)(4) 2016.
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Manufacturer Narrative
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Date sent to fda: 02/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.
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Manufacturer Narrative
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Date sent to fda: 04/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.
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Manufacturer Narrative
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Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.
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Manufacturer Narrative
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Date sent to fda: 04/19/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.
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Search Alerts/Recalls
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