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

Model Number 1DLMCPH06

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

Patient Problems Adhesion(s) (1695); Pain (1994); Obstruction/Occlusion (2422); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4). The initial reporter's complete address is (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 open incisional hernia repair on (b)(6) 2009 whereby a gore dualmesh® plus biomaterial was implanted. It was reported the patient alleges the following injuries: abdominal pain, small bowel obstruction, adhesions, multiple hernia recurrences, mesh revision. 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: kathy titus ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7845600
• MDR Text Key: 119217528
• Report Number: 3003910212-2018-00085
• 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
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/29/2012
• Device Model Number: 1DLMCPH06
• Device Catalogue Number: 1DLMCPH06
• Device Lot Number: 06622659
• 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: 03/11/2009
• 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: 09/05/2018 Patient Sequence Number: 1