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

Model Number 1DLMC04

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Obstruction/Occlusion (2422)

Event Date 09/08/2021

Event Type  Injury  

Event Description

It was reported to gore that the patient underwent laparoscopic ventral incisional hernia repair on (b)(6) 2008 whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2019, (b)(6) 2020, and (b)(6) 2020, additional procedures occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: mesh failure and erosion, infection, inflammation, adhesions and bowel obstruction, producing chronic pain. Additional event specific information was not provided.

Manufacturer Narrative

It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence. " the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ".

• Brand Name: GORE® DUALMESH® 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): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12652366
• MDR Text Key: 280967316
• Report Number: 2017233-2021-02477
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/17/2009
• Device Model Number: 1DLMC04
• Device Catalogue Number: 1DLMC04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2004
• 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: 10/18/2021 Patient Sequence Number: 1