Catalog Number TVTS4 |
Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Pain (1994); Injury (2348); 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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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2014.
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Event Description
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It was reported by an attorney that the patient underwent a sling procedure on (b)(6) 2008.It was reported that she 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).
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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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It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2008, and a mesh was implanted.It was reported that the patient underwent a mesh removal on (b)(6) 2008.It was reported that the patient underwent a gynecological procedure on (b)(6) 2009, and a pelvic autologous rectus fascia mesh was implanted.No additional information was provided.
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Manufacturer Narrative
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It was reported that the surgeon removed the sling after attempted implantation upon finding a urethral injury.(b)(4).
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Manufacturer Narrative
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(b)(4).Reporting period (b)(4) 2014.
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Manufacturer Narrative
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Date sent to the fda: 04/21/2016.(b)(4).Reporting period october 1 2014 through november 30, 2014.
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Manufacturer Narrative
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Additional narrative: it was reported that the patient underwent a gynecological procedure and mesh was implanted concurrently with cystoscopy.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption e2013037.Reporting period (b)(6) 2014 through (b)(6) 2014.(b)(4).
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Manufacturer Narrative
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(b)(4).Reporting period october 1 2014 through november 30, 2014.
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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) 2014.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2014.
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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 october 1 2014 through november 30, 2014.
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Manufacturer Narrative
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(b)(4).Reporting period (b)(4) 2014.
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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) 2014 supplemental report 16 - attachment: [(b)(6) 2014 pah supplemental 16.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 october 1 2014 through november 30, 2014.
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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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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: 04/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2014 through november 30, 2014.
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Manufacturer Narrative
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Date sent to fda: 12/26/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1 2014 through november 30, 2014.
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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 october 1, 2014 through november 30, 2014.
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Search Alerts/Recalls
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