CELLEX CLXUSA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-21 for CELLEX CLXUSA manufactured by Therakos, Inc..

MAUDE Entry Details

Report Number9353625
MDR Report Key9353625
Date Received2019-11-21
Date of Report2019-11-12
Date of Event2019-11-08
Report Date2019-11-12
Date Reported to FDA2019-11-12
Date Reported to Mfgr2019-11-21
Date Added to Maude2019-11-21
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCELLEX
Generic NameSYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
Product CodeLNR
Date Received2019-11-21
Model NumberCLXUSA
Catalog NumberCLXUSA
Lot NumberH338
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTHERAKOS, INC.
Manufacturer Address1425 US ROUTE 206 BEDMINSTER NJ 07921 US 07921


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-21

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