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

Catalog Number	GPSL
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Depression (2361)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 by the patient that they underwent vaginal hysterectomy with anterior and posterior repair on (b)(6) 2009 and mesh was implanted.Following the procedure, the patient experienced mesh erosion, nerve damage, infection, lower back pain, lower leg pain.The patient cannot stand on legs more than 4 hours per day.The patient reported mesh was removed.The patient was taking anti-depressants and was provided antibiotics for infection(s) in the pelvic area.The patient is undergoing physical therapy to gain some strength and is taking vagfem low pessaries.No additional information was provided.

• 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 08876 0151
• MDR Report Key: 7203363
• Report Number: 2210968-2018-70331
• Device Sequence Number: 1174014
• Product Code: OTO
• UDI-Device Identifier: 20705031037738
• UDI-Public: 20705031037738
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K013718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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: ALP841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 01/18/2018
• 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