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

Catalog Number BSGEC60AAC

Device Problems Material Twisted/Bent (2981); Firing Problem (4011)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2021

Event Type  malfunction  

Event Description

Product did not fire properly.Seamguard strings got tangled.Product disposed of and another seamguard was used, which did fire properly.

• 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: 11811781
• MDR Text Key: 250278878
• Report Number: 11811781
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BSGEC60AAC
• Device Lot Number: 22404710
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA