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); Pain (1994); Urinary Tract Infection (2120); Not Applicable (3189)
Date of Event	12/01/2004
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.
Event or Problem Description
It was reported that the patient underwent a gynecological procedure on (b)(6) 2004 and mesh was implanted.The patient reported that the device did not work and another unspecified device was implanted in 2011.The patient reported that she experienced mesh erosion in the vagina and integrated mesh into the back wall of the bladder.The patient also experienced groin, hip and back pain, urinary tract infections, dyspareunia, stress incontinence, discomfort when sitting or standing for long periods and exacerbation of immune response to mesh.The patient has experienced an overall decrease in health, quality of life and marriage.The patient underwent partial mesh removal on (b)(6) 2017.No additional information is available.

• 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: 7352884
• Report Number: 2210968-2018-71527
• Device Sequence Number: 1325725
• Product Code: OTO
• UDI-Device Identifier: 20705031037738
• UDI-Public: 20705031037738
• Combination Product (Y/N): N
• PMA/510(K) Number: K013718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2018

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 Catalogue Number: GPSL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/20/2018
• 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