MAUDE Adverse Event Report: RIVERPOINT MEDICAL VELOSORB; SUTURE

Model Number	CV3110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Device history records for the indicated production lot were reviewed and found to meet all product requirements prior to release.Retain samples were tested for all finished goods testing and all samples passed.This report and use of catergorical 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 part 803.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.- attachment: [071-2019_a complaint 122-2019 reportability assessment.Pdf].
Event or Problem Description
According to the reporter, during an open procedure, while suturing the vagina after birth, the device's thread got loose.A new thread from the same box was used to complete the case.There was no patient injury.".

• Brand Name: VELOSORB
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland OR 97232
• MDR Report Key: 8822405
• Report Number: 3006981798-2019-00008
• Device Sequence Number: 2484951
• Product Code: GAM
• UDI-Device Identifier: 20884521150918
• UDI-Public: 20884521150918
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: CV3110
• Device Lot Number: 16042113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1