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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Manufacturer Narrative
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(b)(4).
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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.The patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.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 - 145.Gynecare tvt secur system - 145.
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Manufacturer Narrative
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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).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).
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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).
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Manufacturer Narrative
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Date sent to the fda: 04/19/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.Supplemental 13.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 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 16 - attachment: [(b)(6) 2015 pah supplemental 16.Xlsx].
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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 february 1, 2015 through march 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 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 february 1, 2015 through march 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 february 1, 2015 through march 31, 2015.
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Manufacturer Narrative
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Date sent to fda: 04/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2015 through march 31, 2015.
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Search Alerts/Recalls
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