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

Model Number	V392
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PGLA ABSORBABLE SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland OR 97232
• MDR Report Key: 9268314
• Report Number: 3006981798-2019-00009
• Device Sequence Number: 13934959
• Product Code: GAM
• UDI-Device Identifier: 10841307130598
• UDI-Public: 10841307130598
• Combination Product (Y/N): N
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/31/2022
• Device Model Number: V392
• Device Lot Number: 17082302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1