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

Catalog Number	GPSL
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Erosion (1750); Incontinence (1928); Neurological Deficit/Dysfunction (1982); Pain (1994); Scarring (2061); Blood Loss (2597); 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.E2013037.Reporting period (b)(6) 2018 through (b)(6) 2018.Total number of events ¿ 17.Additional concomitant medical products: artisyn y-shaped mesh - 3; gynecare gynemesh ps - 14.
Event or Problem Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2009 and mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue, urinary/bowel problems, bleeding, neuromuscular problems and vaginal scarring.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.
Additional Manufacturer Narrative
Date sent to fda: 04/12/2018 ethicon mdr summary reporting exemption e2013037 reporting period december 1, 2018 through january 31, 2018 supplemental 01 - attachment: [02-28-2018 oto supplemental 01.Xlsx].
Additional Manufacturer Narrative
Date sent to fda: 06/23/2018 additional information: d7 h6 patient code: 1928 additional b5 narrative: it was reported that the patient underwent mesh removal on 1/24/2017 due to incontinence.Ethicon mdr summary reporting exemption e2013037 reporting period december 1, 2018 through january 31, 2018 supplemental 02 - attachment: [02-28-2018 oto supplemental 02.Xlsx].
Additional Manufacturer Narrative
Date sent to fda: 08/17/2018 ethicon mdr summary reporting exemption e2013037 reporting period december 1, 2018 through january 31, 2018 supplemental 03 - attachment: [02-28-2018 oto supplemental 03.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 december 1, 2018 through january 31, 2018 supplemental 05 - attachment: [02-28-2018 oto supplemental 05.Xlsx].
Additional Manufacturer Narrative
Date sent to fda: 02/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period december 1, 2017 through january 31, 2018.
Additional Manufacturer Narrative
Date sent to fda: 4/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period december 1, 2018 through january 31, 2018.
Additional Manufacturer Narrative
Date sent to the fda: 12/19/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period december 1, 2017 through january 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: 7289389
• Report Number: 2210968-2018-70989
• Device Sequence Number: 2313970
• Product Code: OTO
• UDI-Device Identifier: 20705031037738
• UDI-Public: 20705031037738
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K013718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/09/2018

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: 07/31/2013
• Device Catalogue Number: GPSL
• Device Lot Number: AME978
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 01/09/2018; 01/09/2018; 01/09/2018; 10/25/2018; 12/27/2018; 02/12/2019; 04/23/2019; 12/19/2019
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 04/12/2018; 06/25/2018; 08/17/2018; 10/25/2018; 12/27/2018; 02/12/2019; 04/23/2019; 12/19/2019
• 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: 58 YR