SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (19CM) H7877001060020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-28 for SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (19CM) H7877001060020 manufactured by Angiodynamics.

MAUDE Entry Details

• Report Number: 1317056-2019-00141
• MDR Report Key: 9244375
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-10-28
• Date of Report: 2019-10-28
• Date of Event: 2019-10-10
• Date Mfgr Received: 2019-10-10
• Device Manufacturer Date: 2018-08-13
• Date Added to Maude: 2019-10-28
• 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: LAW RYAN
• Manufacturer Street: 10 GLENS FALLS TECHNICAL PARK
• Manufacturer City: GLENS FALLS NY 12801
• Manufacturer Country: US
• Manufacturer Postal: 12801
• Manufacturer Phone: 5187424488
• Manufacturer G1: ANGIODYNAMICS
• Manufacturer Street: 10 GLENS FALLS TECHNICAL PARK
• Manufacturer City: GLENS FALLS NY 12801
• Manufacturer Country: US
• Manufacturer Postal Code: 12801
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (19CM)
• Generic Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Product Code: NEY
• Date Received: 2019-10-28
• Catalog Number: H7877001060020
• Lot Number: 5371649
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ANGIODYNAMICS
• Manufacturer Address: 10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US 12801

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-10-28