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

Model Number 1DLMC02

Device Problems Use of Device Problem (1670); Microbial Contamination of Device (2303); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Fistula (1862); Unspecified Infection (1930); Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 04/02/2007

Event Type  Injury  

Manufacturer Narrative

(b)(4). (b)(6). It should be noted that the gore dualmesh® 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 parastomal hernia repair on (b)(6) 2003 whereby a gore dualmesh® biomaterial device was implanted. It was reported that on (b)(6) 2005, laparoscopic repair of a parastomal hernia was performed whereby another gore dualmesh® biomaterial device was implanted. According to the report, the patient underwent laparoscopic ventral hernia repair on (b)(6) 2006 whereby a third gore dualmesh® biomaterial device was implanted. The complaint alleges that on (b)(6) 2007, the gore devices were explanted, and two parastomal mesh devices were implanted. It was reported the patient alleges the following injuries: abdominal pain, nausea and vomiting, dense abdominal adhesions, adhesions to small bowel and colon, multiple bowel obstructions, small bowel perforation, hernia recurrence, additional surgeries to repair hernia, abdominal abscess, open draining wound, and mesh removal. Additional event specific information and medical records were not provided but 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): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kathy titus ; 9285263030
• MDR Report Key: 7639201
• MDR Text Key: 112381350
• Report Number: 2017233-2018-00337
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00733132600953
• UDI-Public: 00733132600953
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/14/2009
• Device Model Number: 1DLMC02
• Device Catalogue Number: 1DLMC02
• Device Lot Number: 02866844
• 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: 01/16/2004
• 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: 06/26/2018 Patient Sequence Number: 1