Catalog Number TVTS |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Incontinence (1928); Unspecified Infection (1930); Pain (1994); Blood Loss (2597)
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Event Type
Injury
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Manufacturer Narrative
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(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 ¿ 8.Tension free vaginal tape ¿ secur - 8.
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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 concurrently with cystoscopy and the mesh was implanted.Following the procedure, the patient experienced pain, urinary problems, recurrence, infection, and bleeding.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)(4) 2017 through (b)(4) 2017.
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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 - 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 october 1, 2017 through november 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 october 1, 2017 through november 30, 2017.
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Manufacturer Narrative
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Date sent to fda: 2/11/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2017 through november 30, 2017.
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Manufacturer Narrative
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Date sent to fda: 4/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2017 through november 30, 2017.
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Search Alerts/Recalls
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