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

Model Number 1DLMC03

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

Patient Problems Adhesion(s) (1695); Not Applicable (3189); No Code Available (3191)

Event Date 08/12/2005

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) 2002 whereby a gore dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2005, an additional procedure was performed whereby explant of the gore device was performed. It was reported the patient alleges the following injuries: removal of mesh, revision surgery, dense adhesions to small bowel, loss of consortium. 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: 7842525
• MDR Text Key: 119109263
• Report Number: 2017233-2018-00534
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/24/2007
• Device Model Number: 1DLMC03
• Device Catalogue Number: 1DLMC03
• Device Lot Number: 01530476
• 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: 06/25/2002
• 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: 09/04/2018 Patient Sequence Number: 1