THERASPHERE 2.79 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 2020-03-24 for THERASPHERE 2.79 GBQ N/A manufactured by Biocompatibles Uk Ltd.

MAUDE Entry Details

Report Number3002124543-2020-00009
MDR Report Key9872169
Report SourceFOREIGN,HEALTH PROFESSIONAL,S
Date Received2020-03-24
Date of Report2020-03-20
Date of Event2015-07-01
Date Mfgr Received2020-03-20
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS SANDRA BAUSBACK-ABALLO
Manufacturer Street300 FOUR FALLS CORPORATE CNTR 300 CONSHOHOCKEN STATE ROAD
Manufacturer CityWEST CONSHOHOCKEN, PA
Manufacturer CountryUS
Manufacturer Phone3311537
Manufacturer G1BIOCOMPATIBLES UK
Manufacturer StreetCHAPMAN HOUSE WEYDON LANE
Manufacturer CityFARNHAM, SURREY
Manufacturer CountryUK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHERASPHERE
Generic NameYTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW, PRODUCT
Product CodeNAW
Date Received2020-03-24
Model Number2.79 GBQ
Catalog NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOCOMPATIBLES UK LTD
Manufacturer AddressCHAPMAN HOUSE FARNHAM BUS PARK WEYDON LANE FARNHAM, GU9 8QL UK GU9 8QL


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.