MAUDE Adverse Event Report: RIVERPOINT MEDICAL VELOSORB FAST; SURGICAL SUTURE

Model Number	CV-9592
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.The lot number of the product was not provided by the user facility.Retain testing was performed on retains of the same product code for all lots manufactured from 2018-2020 and all products met acceptance criteria.A root cause of the event could not be established and the complaint could not be substantiated.This report and use of categorical definitions required by fda 3500a does not constitute an admission by riverpoint medical, or its employees, that riverpoint medical or its employees have caused or contributed to the event described in this report.
Event or Problem Description
According to the reporter, "as head nurse reported the suture was extremely easy to break just getting it out of the package.The surgeon was going to perform an hysterectomy and needed this product to close the fascia; but obviously had to use a different product.".

• Brand Name: VELOSORB FAST
• Common Device Name: SURGICAL SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 11067930
• Report Number: 3006981798-2020-00011
• Device Sequence Number: 14513521
• Product Code: GAM
• UDI-Device Identifier: 20884521153131
• UDI-Public: 20884521153131
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

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: Health Professional
• Device Model Number: CV-9592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1