Catalog Number TVTS4 |
Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)
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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 procedure on (b)(6) 2008 and a sling was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue, recurrence and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.(b)(4).Total number of events ¿ (b)(4).Gynecare tvt secur system - (b)(4).
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(6) 2015.
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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) 2014 through (b)(4) 2015.
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Manufacturer Narrative
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Date sent to the fda: 06/20/2016.(b)(4).Reporting period december 1, 2014 through january 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2014 through (b)(4) 2015.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2014 through (b)(4) 2015.
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Manufacturer Narrative
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(b)(4).Reporting period december 1, 2014 through january 31, 2015.Supplemental 13.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2014 through (b)(6) 2015 supplemental 15 - attachment: [(b)(6) 2015 pah supplemental 15.Xlsx].
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1 2014 through november 30, 2014.
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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 december 1, 2014 through january 31, 2015.
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Manufacturer Narrative
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Date sent to fda: 12/27/2018.Corrected information: marker file ¿12-31-2014 ftl supplemental 23¿ was incorrectly submitted on 10/26/2018 via manufacturer report number 2210968-2014-15475 and will be correctly submitted via 2210968-2014-12913.
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Manufacturer Narrative
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Date sent to fda: 2/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period december 1, 2014 through january 31, 2015.
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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 december 1, 2014 through january 31, 2015.
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Search Alerts/Recalls
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