MAUDE Adverse Event Report: ETHICON INC. GYNEMESH PS (PROLENE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number GPSL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Pain (1994); Scarring (2061); Blood Loss (2597); 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 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).

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue, urinary problems, recurrence, bleeding and vaginal scarring.It was reported that the patient underwent mesh revisions on (b)(6) 2010 and (b)(6) 2016 due to mesh erosion.No additional information was provided.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

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.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 2/11/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 4/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 8/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 12/19/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 2/17/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 06/23/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to the fda: 10/22/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 02/22/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 04/20/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

• Brand Name: GYNEMESH PS (PROLENE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7638900
• MDR Text Key: 112376454
• Report Number: 2210968-2018-73834
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 10705031037731
• UDI-Public: 10705031037731
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: GPSL
• Device Catalogue Number: GPSL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR