MAUDE Adverse Event Report: RIVERPOINT MEDICAL VELOSORB FAST; PGLA

Model Number	CV-917
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
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.Additional product from this lot was tested and found to pass all performance specifications.Product was returned to the distributor and found to have markings indicating mishandling of the product resulting in damage to the needle and suture.Distributor did not return device.
Event or Problem Description
According to the reporter, at the end of the perineal suture in an obstetrics surgery, the thread loosened from the curved needle and the needle became dislodged in the subcutaneous tissue of the patient's buttock.The physician therefore defeated the suture and performed a radiological examination to recover the needle.An x-ray was performed on the same date as the surgery.The doctor had to use a new suture and put the patient under prophylactic antibiotic therapy to complete the case.The patient was alive with no injury.

• Brand Name: VELOSORB FAST
• Common Device Name: PGLA
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 7398143
• Report Number: 3006981798-2018-00007
• Device Sequence Number: 13470316
• Product Code: GAM
• UDI-Device Identifier: 10884521151659
• UDI-Public: 10884521151659
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: CV-917
• Device Catalogue Number: CV-917
• Device Lot Number: 16120122X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2017
• Initial Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention