MAUDE Adverse Event Report: C. R. BARD, INC. VENTRALIGHT ST MESH WITH ECHO POSITIONING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 5955800

Device Problems Inflation Problem (1310); Appropriate Term/Code Not Available (3191)

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

Event Date 07/16/2018

Event Type  Injury  

Event Description

Ventralight st mesh with echo positioning system being used for hernia repair.Echo positioning system malfunctioned and would not inflate as designed.Positioning system was withdrawn and mesh was found to be in satisfactory position despite malfunction.

• Brand Name: VENTRALIGHT ST MESH WITH ECHO POSITIONING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 7731252
• MDR Text Key: 115541681
• Report Number: MW5078687
• 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: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 5955800
• Device Lot Number: HUBP1223
• Was Device Available for Evaluation?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR