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

Model Number GKFV1520

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

The initial reporter's complete address is (b)(6). Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: please see the attached file for information ascertained from the medical records. It should be noted that the gore® synecor intraperitoneal 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 ventral hernia repair on (b)(6) 2007 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on(b)(6) 2017, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: mesh removal, pain, adhesions, wound vac, additional surgery. Additional event specific information was not provided.

• Brand Name: GORE® SYNECOR INTRAPERITONEAL 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: katheryn fox ; 9285263030
• MDR Report Key: 12682599
• MDR Text Key: 277943949
• Report Number: 3003910212-2021-00004
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/24/2019
• Device Model Number: GKFV1520
• Device Catalogue Number: GKFV1520
• Device Lot Number: 15625679
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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: 10/22/2021 Patient Sequence Number: 1