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

Model Number 1DLMCP02

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

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Discharge (2225); Hernia (2240)

Event Date 08/22/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4). (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: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material¿. ¿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¿.

Event Description

It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2006 whereby a gore dualmesh® plus biomaterial was implanted. It was reported the patient also underwent open repair of an incisional hernia on (b)(6) 2006 whereby a second gore dualmesh® plus biomaterial was implanted. The complaint alleges that two explant procedures were performed on (b)(6) 2011 and (b)(6) 2012. It was reported the patient alleges the following injuries: hernia recurrence, adhesions, mesh removal, draining sinus tract, and mesh infection. Additional event specific information and medical records have been requested.

• 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: 7641121
• MDR Text Key: 112433924
• Report Number: 2017233-2018-00350
• 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: Other Caregivers
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/20/2009
• Device Model Number: 1DLMCP02
• Device Catalogue Number: 1DLMCP02
• Device Lot Number: 04518356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2006
• 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: 06/27/2018 Patient Sequence Number: 1