MAUDE Adverse Event Report: RIVERPOINT MEDICAL VILET; PGLA ABSORBABLE SUTURE

Model Number V392

Device Problem Material Fragmentation (1261)

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

Event Date 06/27/2018

Event Type  malfunction  

Event Description

According to the reporter, "suturing an extraction site, the needle came off the suture 2 times." product retains from the same lot were tested for finished goods testing and all samples passed.Trend analysis shows that this is the first complaint for this product since initial release.

• Brand Name: VILET
• Type of Device: PGLA ABSORBABLE SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave.; portland, OR 97232 ; 5035178001
• MDR Report Key: 9268314
• MDR Text Key: 206362092
• Report Number: 3006981798-2019-00009
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10841307130598
• UDI-Public: 10841307130598
• Combination Product (y/n): N
• PMA/PMN Number: K120556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2022
• Device Model Number: V392
• Device Lot Number: 17082302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1