MRI SEEDNET?GOLD CONSOLE FPRCH2033

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-27 for MRI SEEDNET?GOLD CONSOLE FPRCH2033 manufactured by Galil Medical Ltd..

MAUDE Entry Details

• Report Number: 3004462490-2020-00001
• MDR Report Key: 9766520
• Report Source: COMPANY REPRESENTATIVE,DISTRI
• Date Received: 2020-02-27
• Date of Report: 2020-02-27
• Date of Event: 2020-01-28
• Date Mfgr Received: 2020-01-28
• Device Manufacturer Date: 2010-11-04
• Date Added to Maude: 2020-02-27
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. SANDRA BAUSBACK-ABALLO
• Manufacturer Street: 300 CONSHOHOCKEN STATE RD, 300 FOUR FALLS CORPORATE CTR.
• Manufacturer City: WEST CONSHOHOCKEN, PA
• Manufacturer Country: US
• Manufacturer Phone: 3311537
• Manufacturer G1: GALIL MEDICAL LTD.
• Manufacturer Street: 4364 ROUND LAKE ROAD W
• Manufacturer City: ARDEN HILLS, MN
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MRI SEEDNET?GOLD CONSOLE
• Generic Name: CRYOSURGICAL DEVICES AND ACCESSORIES
• Product Code: GEH
• Date Received: 2020-02-27
• Returned To Mfg: 2020-02-13
• Model Number: FPRCH2033
• Catalog Number: FPRCH2033
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GALIL MEDICAL LTD.
• Manufacturer Address: 1 TAVOR BUILDING P.O. BOX 224, INDUSTRIAL PARK YOKNEAM, 2069203,, IS 2069203,,

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-27