MAUDE Adverse Event Report: ETHICON INC. GYNECARE GYNEMSH PS 4INX6IN; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number GPSL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and mesh was implanted.It was reported that the patient experienced undisclosed adverse event.No additional information was provided.

Manufacturer Narrative

A review of the batch manufacturing records was conducted an cd the batch met all finished goods release criteria.

• Brand Name: GYNECARE GYNEMSH PS 4INX6IN
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10143319
• MDR Text Key: 194801725
• Report Number: 2210968-2020-04479
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Model Number: GPSL
• Device Catalogue Number: GPSL
• Device Lot Number: ZJP293
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1