THERASPHERE 5.2 GBQ N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2019-10-03 for THERASPHERE 5.2 GBQ N/A manufactured by Biocompatibles Uk Ltd.

MAUDE Entry Details

• Report Number: 3002124543-2019-00059
• MDR Report Key: 9151149
• Report Source: FOREIGN,HEALTH PROFESSIONAL,S
• Date Received: 2019-10-03
• Date of Report: 2019-10-02
• Date of Event: 2017-01-22
• Date Mfgr Received: 2019-10-02
• Date Added to Maude: 2019-10-03
• 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: MS SANDRA BAUSBACK-ABALLO
• Manufacturer Street: 300 FOUR FALLS CORPORATE CENTE 300 CONSHOHOCKEN STATE ROAD
• Manufacturer City: WEST CONSHOHOCKEN, PA 194282998
• Manufacturer Country: US
• Manufacturer Postal: 194282998
• Manufacturer Phone: 6103311537
• Manufacturer G1: BIOCOMPATIBLES UK
• Manufacturer Street: CHAPMAN HOUSE WEYDON LANE
• Manufacturer City: FARNHAM, GU9 8QL
• Manufacturer Country: UK
• Manufacturer Postal Code: GU9 8QL
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THERASPHERE
• Generic Name: YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW
• Product Code: NAW
• Date Received: 2019-10-03
• Model Number: 5.2 GBQ
• Catalog Number: N/A
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOCOMPATIBLES UK LTD
• Manufacturer Address: CHAPMAN HOUSE FARNHAM BUS PARK WEYDON LANE FARNHAM, GU9 8QL UK GU9 8QL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2019-10-03