MAUDE Adverse Event Report: DAVOL INC. VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM; MESH, SURGICAL, POLYMERIC

Model Number 5955600

Device Problem Material Fragmentation (1261)

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

Event Date 01/13/2020

Event Type  malfunction  

Event Description

Ventralight st mesh with echo ps positioning system was used on patient.There was a small yellow piece of silicone that popped off the positioner while in the abdomen.The piece was unable to be retrieved.

• Brand Name: VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): DAVOL INC.; 160 new boston st; woburn MA 01801
• MDR Report Key: 9732403
• MDR Text Key: 180147882
• Report Number: 9732403
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5955600
• Device Catalogue Number: 5955600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15695 DA