MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. SEAMGUARD; MESH, SURGICAL, POLYMERIC

Catalog Number 12BSGEC60A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2020

Event Type  malfunction  

Event Description

Product defect: seamguard.2 items from the same lot.First seamguard had a rip in the fabric.Second seamguard had the string break after it was already deployed in the patient.Surgeon was able to retrieve all bits of string but it was broken.

• Brand Name: SEAMGUARD
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 301 airport rd.; elkton MD 21921
• MDR Report Key: 10069930
• MDR Text Key: 191430369
• Report Number: 10069930
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12BSGEC60A
• Device Lot Number: 21632003
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7665 DA