MAUDE Adverse Event Report: BARD SHANNON LIMITED BARD VENTRALIGHT ST MESH WITH ECHO 2 POSITIONING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 5992025

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 12/04/2019

Event Type  malfunction  

Event Description

During a ventral hernia repair with mesh, the mesh fell apart inside the pt.The 2 pieces that came off were located and removed by the surgeon.Fda safety report id# (b)(4).

• Brand Name: BARD VENTRALIGHT ST MESH WITH ECHO 2 POSITIONING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BARD SHANNON LIMITED
• MDR Report Key: 9491031
• MDR Text Key: 171983629
• Report Number: MW5091734
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Catalogue Number: 5992025
• Device Lot Number: HUDS1615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1