MAUDE Adverse Event Report: RIVERPOINT MEDICAL VELOSORB FAST; PGLA QUICK

Model Number	SV-2298
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.A review of the device history record was performed and no issues were noted with the lot during production and all samples tested passed finished goods inspection prior to release.Retains from the same lot were tested for all finished goods testing, including needle attachment and tensile strength, all samples passed.
Event or Problem Description
According to the reporter, "intra-operatively, the device needle came off from the thread and fell into the patient cavity.The needle remained inside the patient perineum.Due to the product issue the patient had to go another procedure in order to removed (sic) the component inside the cavity.The patient also had to extend hospital stay due to the problem.".

• Brand Name: VELOSORB FAST
• Common Device Name: PGLA QUICK
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 10928986
• Report Number: 3006981798-2020-00009
• Device Sequence Number: 14069735
• Product Code: GAM
• UDI-Device Identifier: 20884521151021
• UDI-Public: 20884521151021
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 12/01/2020

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: 03/31/2021
• Device Model Number: SV-2298
• Device Lot Number: 18042519FX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/01/2020
• 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: Hospitalization; Required Intervention