MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP BAXTER VASCUGUARD PERIPHERAL PATCH

Model Number	VG0108N
Health Effect - Clinical Code	Swelling (2091)
Date of Event	08/07/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Baxter vascuguard peripheral patch was applied during an endarterectomy on (b)(6) 2016.On (b)(6) 2016, the pt returned to the emergency department with complaints of neck swelling at the surgical site.A surgical revision was performed.The patch was not intact.

• Brand Name: BAXTER VASCUGUARD PERIPHERAL PATCH
• Common Device Name: BAXTER VASCUGUARD PERIPHERAL PATCH
• Manufacturer (Section D): BAXTER HEALTHCARE CORP; deerfield IL 60015
• MDR Report Key: 5903577
• Report Number: MW5064330
• Device Sequence Number: 16220250
• Product Code: DXZ
• UDI-Device Identifier: 00085412530895
• UDI-Public: (01)00085412530895(17)210211(10)
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2021
• Device Model Number: VG0108N
• Device Catalogue Number: PN321301080011
• Device Lot Number: SP16B221123983
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2016
• 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
• Patient Age: 65 YR
• Patient Weight: 88