MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC VELOSORB FAST; BRAIDED FAST ABSORBABLE SUTURE

Model Number	SV-2920
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation.A review of the device history record was performed and all product met requirements prior to release.Product retains from the same lot of product were tested for finished goods testing, which included tensile strength and moisture testing, all samples passed.The report could not be substantiated and a cause for the event cannot be established.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.Riverpoint medical has filed this information to comply with the medical device reporting regulation 21 cfr 803.If additional information is provided by riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.
Event or Problem Description
According to the reporter, "following a laparoscopic septoplasty and functional endoscopic sinus surgery where the device was used for skin closure, tissue damage was noted.There was a possible dehiscence and there was a granulomas forming.".

• Brand Name: VELOSORB FAST
• Common Device Name: BRAIDED FAST ABSORBABLE SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232 ; 5035178001
• MDR Report Key: 14780775
• Report Number: 3006981798-2022-00020
• Device Sequence Number: 6107822
• Product Code: GAM
• UDI-Device Identifier: 20884521152257
• UDI-Public: 20884521152257
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: SV-2920
• Device Lot Number: 21062114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown