Catalog Number GPSL |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Erosion (1750); Pain (1994); No Code Available (3191)
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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 ¿ (b)(4).Artisyn y-shaped mesh ¿ 1.Artisyn y-shaped mesh unknown product ¿ 2.Gynecare gynemesh ¿ 37.Gynecare gynemesh* ps ¿ 53.
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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.Following the procedure, the patient experienced pain, and erosion and underwent revision procedures.No further information is available.
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Manufacturer Narrative
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Date sent to fda: (b)(6)2018.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2017 through may 31, 2017.Supplemental 04 - attachment: [06-30-2017 oto supplemental 04.Xlsx].
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2017 through may 31, 2017.
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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 (b)(6) 2017 through (b)(6) 2017 supplemental 03 - attachment: [(b)(6) 2017 oto supplemental 03.Xlsx].
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2017 through may 31, 2017.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2017 through may 31, 2017.
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Manufacturer Narrative
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Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2017 through may 31, 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 april 1, 2017 through may 31, 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 april 1, 2017 through may 31, 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 april 1, 2017 through may 31, 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 april 1, 2017 through may 31, 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 april 1, 2017 through may 31, 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 april 1, 2017 through may 31, 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 april 1, 2017 through may 31, 2017.
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Search Alerts/Recalls
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