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

Model Number 1DLMCP04

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Pain (1994); Hernia (2240); Not Applicable (3189); No Code Available (3191)

Event Date 05/14/2013

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: ¿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) 2012, whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2013, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: pain, bulge, recurrent hernia, removal of mesh, additional surgery. 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): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: marcos ayala ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8377783
• MDR Text Key: 137393747
• Report Number: 3003910212-2019-00041
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/31/2014
• Device Model Number: 1DLMCP04
• Device Catalogue Number: 1DLMCP04
• Device Lot Number: 8910390
• 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: 02/03/2011
• 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: 02/28/2019 Patient Sequence Number: 1