Catalog Number TVTS4 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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Date sent to the fda: 10/26/2017.(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.If the device or further details are received at the later date, a supplemental medwatch will be sent.(b)(4).Total number of events ¿ (b)(4).Tension free vaginal tape ¿ secur - (b)(4).
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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) 2009 and the mesh was implanted.The patient underwent a sling excision procedure on (b)(6) 2015.No further information is available.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2017 through (b)(6) 2017 supplemental 01 *includes 36 initial files omitted from (b)(6) 2017 submission: tension free vaginal tape ¿ secur - 36 - attachment: [(b)(6) 2017 pah supplemental 01.Xlsx].
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period august 1, 2017 through september 30, 2017.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period august 1, 2017 through september 30, 2017.
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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) 2017 through (b)(4) 2017.
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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 august 1, 2017 through september 30, 2017.
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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 august 1, 2017 through september 30, 2017.
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Manufacturer Narrative
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Date sent to fda: 4/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
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Manufacturer Narrative
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Date sent to fda: 06/26/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
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Manufacturer Narrative
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Date sent to fda: 10/28/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
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Manufacturer Narrative
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Date sent to the fda: 12/19/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
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Manufacturer Narrative
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Date sent to fda: 02/18/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
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Manufacturer Narrative
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Date sent to fda: 06/23/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
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Manufacturer Narrative
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Date sent to fda: 10/22/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
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Manufacturer Narrative
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Date sent to the fda: 02/19/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
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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 august 1, 2017 through september 30, 2017.
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Manufacturer Narrative
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Date sent to fda: 06/18/2021.
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Search Alerts/Recalls
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