PROSORBA COLUMN 9798701

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-08-10 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.

Event Text Entries

[435474] Patient developed lower leg pain and "vein distension" on right leg after 2 treatments. Diagnosed with superficial venous thrombosis. Patient was anticogulated and discharged. Patient was being treated for an off-label condition mgus associated neuropathy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3032792-2005-00016
MDR Report Key625813
Report Source05
Date Received2005-08-10
Date of Event2005-07-14
Date Mfgr Received2005-07-14
Device Manufacturer Date2005-01-01
Date Added to Maude2005-08-15
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 Location0
Manufacturer ContactJOE WINSLOW
Manufacturer Street14715 NE 95TH ST, STE 100
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal98052
Manufacturer Phone4252422000
Manufacturer G1FRESENIUS HEMOCARE
Manufacturer Street14715 NE 95TH ST, STE 100
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal Code98052
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROSORBA COLUMN
Generic NameIMMUNOADSORPTION COLUMN
Product CodeLQQ
Date Received2005-08-10
Model Number9798701
Catalog Number9798701
Lot NumberRAN002C
ID Number*
Device Expiration Date2006-07-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key615441
ManufacturerFRESENIUS HEMOCARE
Manufacturer Address* REDMOND WA * US
Baseline Brand NamePROSORBA COLUMN
Baseline Generic NameTHERAPEUTIC PLASMA EXCHA
Baseline Catalog No9798701
Baseline Device FamilyPROTEIN A IMMUNOADSORPTION COL
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]12
Baseline PMA FlagY
Premarket ApprovalP8500
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2005-08-10

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