Catalog Number GPSXL3 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problems
Erosion (1750); Pain (1994); No Code Available (3191)
|
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).Artisyn y-shaped mesh unknown product ¿ (b)(4).Gynecare gynemesh ¿ (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)2007 and the mesh was implanted.Following the procedure, the patient experienced pain and erosion and underwent revision procedures.No further information is available.
|
|
Manufacturer Narrative
|
Date sent to the fda: 12/28/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2017 through (b)(4) 2017.(b)(4).
|
|
Manufacturer Narrative
|
Ethicon mdr summary reporting exemption (b)(4).Reporting period june 1, 2017 through july 31, 2017.
|
|
Manufacturer Narrative
|
Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2017 through (b)(6) 2017 supplemental 01 - attachment: [(b)(6) 2017 oto supplemental 01.Xlsx].
|
|
Manufacturer Narrative
|
Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2017 through (b)(4) 2017.
|
|
Manufacturer Narrative
|
Ethicon mdr summary reporting exemption (b)(4).Reporting period june 1, 2017 through july 31, 2017.
|
|
Manufacturer Narrative
|
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 june 1, 2017 through july 31, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 2/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2017 through july 31, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 4/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2017 through july 31, 2017.
|
|
Manufacturer Narrative
|
Date sent to the fda: 12/19/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2017 through july 31, 2017.
|
|
Manufacturer Narrative
|
Date sent to the fda: 02/19/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2017 through july 31, 2017.
|
|
Manufacturer Narrative
|
Date sent to fda: 04/19/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2017 through july 31, 2017.
|
|
Search Alerts/Recalls
|