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

Model Number	GPSL
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Pain (1994); Scarring (2061); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional 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.Ethicon mdr summary reporting e2013037.Reporting period february 1, 2018 through march 31, 2018.Total number of events ¿ 160, artisyn y-shaped mesh - 2, gynecare gynemesh ps - 158.
Event or Problem Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and mesh was implanted.  it was reported that she experienced pain, erosion of her internal bodily tissue, cystocele, infection, urinary problems, dyspareunia and vaginal scarring. the patient underwent cystoscopy; robotically assisted laparoscopic resection of sacral colon (b)(6) 2016.On (b)(6) 2017, the patient underwent cystocele repair using a cell and cystoscopy.No additional information was provided.
Additional Manufacturer Narrative
Date sent to fda: 06/26/2018 ethicon mdr summary reporting exemption e2013037 reporting period february 1, 2018 through march 31, 2018 supplemental 01 - attachment: [04-30-2018 oto supplemental 01.Xlsx].
Additional Manufacturer Narrative
Date sent to fda: 08/17/2018 ethicon mdr summary reporting exemption e2013037 reporting period february 1, 2018 through march 31, 2018 supplemental 02 - attachment: [04-30-2018 oto supplemental 02.Xlsx].
Additional 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.
Additional Manufacturer Narrative
Date sent to fda: 12/27/2018 ethicon mdr summary reporting exemption e2013037 reporting period february 1, 2018 through march 31, 2018 supplemental 04 - attachment: [04-30-2018 oto supplemental 04.Xlsx].
Additional Manufacturer Narrative
Date sent to fda: 02/11/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2018 through march 31, 2018.
Additional Manufacturer Narrative
Date sent to fda: 4/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2018 through march 31, 2018.
Additional Manufacturer Narrative
Date sent to fda: 2/18/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2018 through march 31, 2018.
Additional Manufacturer Narrative
Date sent to the fda: 10/22/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2018 through march 31, 2018.
Additional Manufacturer Narrative
Date sent to fda: 12/22/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2018 through march 31, 2018.
Additional Manufacturer Narrative
Date sent to fda: 04/19/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2018 through march 31, 2018.
Additional Manufacturer Narrative
Date sent to fda: 02/19/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2018 through march 31, 2018.

• Brand Name: GYNEMESH PS (PROLENE
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7422756
• Report Number: 2210968-2018-72086
• Device Sequence Number: 13470198
• Product Code: OTO
• UDI-Device Identifier: 20705031037738
• UDI-Public: 20705031037738
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K013718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: GPSL
• Device Catalogue Number: GPSL
• Device Lot Number: EGE944
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018; 03/07/2018; 10/25/2018; 12/27/2018; 02/11/2019; 04/23/2019; 02/18/2020; 10/22/2020; 12/22/2020; 02/19/2021; 04/19/2021
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/26/2018; 08/17/2018; 10/25/2018; 12/27/2018; 02/11/2019; 04/23/2019; 02/18/2020; 10/22/2020; 12/22/2020; 02/19/2021; 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR