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

Catalog Number 1DLMCP07

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® plus 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® 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) 2009 whereby a gore® dualmesh® plus biomaterial was implanted.It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2016 whereby two gore® dualmesh® plus biomaterial were implanted.The complaint alleges that on (b)(6) 2016, an additional procedure occurred whereby the gore devices was explanted.It was reported the patient alleges the following injuries: dehiscence of mesh, mesh infection and removal additional event specific information was not provided.

Manufacturer Narrative

Nature event code 4316-z: appropriate term/code not available is being used for "duplicate claim".3.See mfr report#: 3003910212-2019-00379.

Manufacturer Narrative

H6: code 4316 (appropriate term/code not available) is being used for: duplicate complaint.See mfr report #3003910212-2019-00377.

• Brand Name: GORE DUALMESH® PLUS BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9284060
• MDR Text Key: 165372750
• Report Number: 2017233-2019-01122
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00733132601141
• UDI-Public: 00733132601141
• Combination Product (y/n): N
• PMA/PMN Number: K063435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Catalogue Number: 1DLMCP07
• Device Lot Number: 05864667
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR