MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC

Model Number 1DLMCP04

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/10/2011

Event Type  Injury  

Event Description

It was reported to gore that the patient underwent incisional hernia repair on (b)(6) 2011 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2011, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: mesh removal, infection, abscess, seroma, pain and suffering. Additional event specific information was not provided.

Event Description

It was reported to gore that the patient underwent incisional hernia repair on (b)(6) 2011 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2011, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: mesh removal, infection, abscess, seroma, pain and suffering. Additional event specific information was not provided.

• Brand Name: GORE® DUALMESH® PLUS BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13319105
• MDR Text Key: 286076661
• Report Number: 3003910212-2022-01328
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K063435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/31/2012
• Device Model Number: 1DLMCP04
• Device Catalogue Number: 1DLMCP04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/21/2022 Patient Sequence Number: 1