Catalog Number TVTS4 |
Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Pain (1994); Surgical procedure (2357)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2006 and a sling was implanted.It was reported that the patient experienced pain, erosion of her internal bodily tissue 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).Reporting period (b)(4) 2015.
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Manufacturer Narrative
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(b)(4).Reporting period (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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(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) 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2015.Supplemental 12.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2015 through may 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2015 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).Reporting period april 1, 2015 through may 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2015 through (b)(6) 2015 supplemental 14 - attachment: [(b)(6) 2015 pah supplemental 14.Xlsx].
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2015 through may 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2015 through may 31, 2015.
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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 april 1, 2015 through may 31, 2015.
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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 april 1, 2015 through may 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 april 1, 2015 through may 31, 2015.
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Search Alerts/Recalls
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