Catalog Number TVTS |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Erosion (1750); Pain (1994); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Surgical intervention.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.(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) 2007 and mesh was implanted.It was reported that the patient underwent another gynecological surgical procedure on (b)(6) 2008 and mesh was implanted.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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Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2018 through march 31, 2018.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2018 through march 31, 2018.
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Manufacturer Narrative
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Pc-(b)(4).Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037
reporting period (b)(4) 2018 through (b)(4) 2018.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2018 through march 31, 2018.
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Manufacturer Narrative
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Date sent to fda: 02/11/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2018 through march 31, 2018.
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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 february 1, 2018 through march 31, 2018.
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Manufacturer Narrative
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Date sent to fda: 2/18/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2018 through march 31, 2018.
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Manufacturer Narrative
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Date sent to fda: 9/3/2019.
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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 february 1, 2018 through march 31, 2018.
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Manufacturer Narrative
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Date sent to fda: 02/19/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2018 through march 31, 2018.
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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 february 1, 2018 through march 31, 2018.
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Search Alerts/Recalls
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