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

Model Number 1DLMC07

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

Patient Problems Purulent Discharge (1812); Fistula (1862); Granuloma (1876); Unspecified Infection (1930); Seroma (2069); Discharge (2225)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6). 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 incisional hernia repair on (b)(6) 2014 whereby a gore dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2017, an additional procedure was performed whereby explant of the gore device was performed. It was reported the patient alleges the following injuries: open draining wound, granuloma, infected mesh, mesh removal. Additional event specific information and medical records have been requested.

• Brand Name: GORE DUALMESH BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: kathy titus ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7641345
• MDR Text Key: 112443235
• Report Number: 3003910212-2018-00054
• 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: 08/03/2020

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: 08/31/2018
• Device Model Number: 1DLMC07
• Device Catalogue Number: 1DLMC07
• Device Lot Number: 11777873
• 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: 09/25/2013
• 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