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

Model Number 1DLMCP05

Device Problems Contamination (1120); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6). It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and 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® plus 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. ¿.

Event Description

It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2005 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: pain, additional surgery, mesh removal, infection. 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; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kathy titus ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 8266814
• MDR Text Key: 133718325
• Report Number: 2017233-2019-00042
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/16/2005
• Device Model Number: 1DLMCP05
• Device Catalogue Number: 1DLMCP05
• Device Lot Number: 02762429
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2003
• 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: 01/22/2019 Patient Sequence Number: 1