|
Catalog Number GPSL34 |
Device Problem
Migration (4003)
|
Patient Problems
Erosion (1750); Not Applicable (3189)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).To date the device has not been returned.If the device or further details are received at the 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.Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2018 through november 30, 2018 (b)(4).Total number of events ¿ 35; artisyn y-shaped mesh - 1; gynecare gynemesh ps - 34.
|
|
Event Description
|
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and the mesh was implanted due to pelvic organ prolapse, cystocele, rectocele, enterocele, stress urinary incontinence and adhesions.It was reported that the patient underwent mesh removal surgery on (b)(6) 2014 due to exposed mesh.No further information is available.
|
|
Manufacturer Narrative
|
Date sent to fda: 2/11/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.
|
|
Manufacturer Narrative
|
Date sent to fda: 4/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.
|
|
Manufacturer Narrative
|
Date sent to fda: 04/26/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.
|
|
Search Alerts/Recalls
|
|
|