CRYOPATCH SG PULMONARY BRANCH SGP020

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 2019-09-09 for CRYOPATCH SG PULMONARY BRANCH SGP020 manufactured by Cryolife, Inc. ? Kennesaw.

MAUDE Entry Details

• Report Number: 1063481-2019-00049
• MDR Report Key: 8974341
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-09-09
• Date of Report: 2019-10-11
• Date of Event: 2019-07-18
• Date Facility Aware: 2019-08-29
• Date Mfgr Received: 2019-08-29
• Date Added to Maude: 2019-09-09
• 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: ROCHELLE MANEY
• Manufacturer Street: 1655 ROBERTS BLVD. NW
• Manufacturer City: KENNESAW GA 30144
• Manufacturer Country: US
• Manufacturer Postal: 30144
• Manufacturer Phone: 7704193355
• Manufacturer G1: CRYOLIFE, INC.
• Manufacturer Street: 1655 ROBERTS BLVD. NW
• Manufacturer City: KENNESAW GA 30144
• Manufacturer Country: US
• Manufacturer Postal Code: 30144
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CRYOPATCH SG PULMONARY BRANCH
• Generic Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Product Code: DXZ
• Date Received: 2019-09-09
• Model Number: SGP020
• Catalog Number: SGP020
• Lot Number: 147776
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CRYOLIFE, INC. ? KENNESAW
• Manufacturer Address: 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2019-09-09