PROXICOR FOR PERICARDIAL CLOSURE CMCV-060-402

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-06-25 for PROXICOR FOR PERICARDIAL CLOSURE CMCV-060-402 manufactured by Aziyo Biologics, Inc..

MAUDE Entry Details

• Report Number: 3005619880-2019-00006
• MDR Report Key: 8732662
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-06-25
• Date of Report: 2019-06-25
• Date of Event: 2019-05-20
• Date Mfgr Received: 2019-05-29
• Device Manufacturer Date: 2019-03-01
• Date Added to Maude: 2019-06-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. ANDREW GREEN
• Manufacturer Street: 1100 OLD ELLIS ROAD STE 1200
• Manufacturer City: ROSWELL GA 30076
• Manufacturer Country: US
• Manufacturer Postal: 30076
• Manufacturer G1: AZIYO BIOLOGICS, INC.
• Manufacturer Street: 1100 OLD ELLIS ROAD STE 1200
• Manufacturer City: ROSWELL GA 30076
• Manufacturer Country: US
• Manufacturer Postal Code: 30076
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PROXICOR FOR PERICARDIAL CLOSURE
• Generic Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Product Code: DXZ
• Date Received: 2019-06-25
• Model Number: CMCV-060-402
• Lot Number: M19B1070
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AZIYO BIOLOGICS, INC.
• Manufacturer Address: 1100 OLD ELLIS ROAD STE 1200 ROSWELL GA 30076 US 30076

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2019-06-25