Catalog Number ARTY |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problems
Erosion (1750); Pain (1994); Not Applicable (3189)
|
Event Type
Injury
|
Manufacturer Narrative
|
(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 ¿ (b)(4).Gynecare gynemesh ps - (b)(4).
|
|
Event Description
|
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2014 and the mesh was implanted.Following the procedure, the patient experienced pain and erosion of internal bodily tissue.It was also reported that the patient underwent revisionary procedures.No additional information was provided.
|
|
Manufacturer Narrative
|
Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2017 through (b)(6) 2017 supplemental 01 *includes 20 initial files omitted from (b)(6) 2017 submission: artisyn y-shaped mesh ¿ 0 gynecare gynemesh - 10 gynecare gynemesh ps ¿ 10 - attachment: [(b)(6) 2017 oto supplemental 01.Xlsx].
|
|
Manufacturer Narrative
|
Ethicon mdr summary reporting exemption (b)(4).Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2017 through (b)(6) 2017 supplemental 02 - attachment: [(b)(6) 2017 oto supplemental 02.Xlsx].
|
|
Manufacturer Narrative
|
Ethicon mdr summary reporting exemption (b)(4).Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037
reporting period (b)(4) 2017 through (b)(4) 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 2/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 4/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 06/25/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 08/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 10/28/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to the fda: 12/19/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 02/18/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 08/24/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 10/22/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to the fda: 02/19/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 04/19/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2017 through september 30, 2017.
|
|
Search Alerts/Recalls
|