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

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Hernia (2240)

Event Date 01/10/2007

Event Type  Injury  

Manufacturer Narrative

(b)(4). (b)(6). Product identification records for the alleged gore device was not provided. Therefore, a review of the manufacturing records could not be performed. It should be noted that the gore dualmesh® 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 open incisional hernia repair on (b)(6) 2001 whereby an alleged gore device was implanted. The complaint alleges that on (b)(6) 2002, the patient again underwent open incisional hernia repair whereby a gore dualmesh® plus biomaterial was implanted. It was reported that an additional procedure was performed on (b)(6) 2007 whereby the gore devices were explanted. It was reported the patient alleges the following injuries: abdominal pain and discomfort, hernia recurrence, extensive adhesions, mesh infection, and mesh removal. Additional event specific information was not provided.

• Brand Name: GORE DUALMESH 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: 7641004
• MDR Text Key: 112424175
• Report Number: 2017233-2018-00343
• 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
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/15/2020

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

• 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
• 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