CELLEX PHOTOPHERESIS SYSTEM NOT APPLICABLE CLXUSA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-13 for CELLEX PHOTOPHERESIS SYSTEM NOT APPLICABLE CLXUSA manufactured by Therakos.

MAUDE Entry Details

Report Number2523595-2020-00036
MDR Report Key9828711
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-13
Date of Report2020-03-26
Date of Event2020-02-13
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-08-14
Date Added to Maude2020-03-13
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 ContactMEGAN VERNAK
Manufacturer Street1425 US ROUTE 206
Manufacturer CityBEDMINSTER, NJ
Manufacturer CountryUS
Manufacturer G1MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Manufacturer StreetCOLLEGE BUSINESS & TECH PARK CRUISERATH ROAD
Manufacturer CityBLANCHARDSTOWN, DUBLIN, D15 TX2V
Manufacturer CountryEI
Manufacturer Postal CodeD15 TX2V
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCELLEX PHOTOPHERESIS SYSTEM
Generic NameCELLEX PHOTOPHERESIS SYSTEM
Product CodeLNR
Date Received2020-03-13
Returned To Mfg2020-03-02
Model NumberNOT APPLICABLE
Catalog NumberCLXUSA
Lot NumberH348
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTHERAKOS
Manufacturer Address1425 US ROUTE 206 BEDMINSTER, NJ US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-13

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