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 2004-10-01 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare, Inc..

Event Text Entries

[338233] Pt admitted to hosp 10 days after 8th prosorba treatment and diagnosed with multiple pulmonary emboli. Pt had been taking aspirin and had no history of thrombotic events. Pt was anticoagulated and discharged on coumadin. According to their physician, their dyspnea is resolving. No further prosorba treatments will be done.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3032792-2004-00008
MDR Report Key547447
Report Source05
Date Received2004-10-01
Date of Report2004-10-01
Date of Event2004-09-07
Date Facility Aware2004-09-08
Date Mfgr Received2004-09-07
Device Manufacturer Date2004-01-01
Date Added to Maude2004-10-08
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 ContactKAREN QUARFORD
Manufacturer Street14715 NE 95 ST, SUITE 100
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal98052
Manufacturer Phone4252422154
Manufacturer G1FRESENIUS HEMOCARE, INC.
Manufacturer Street14715 NE 95TH ST, SUITE 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 NamePROSORBA COLUMN
Product CodeLQQ
Date Received2004-10-01
Model Number9798701
Catalog Number9798701
Lot NumberQAN001F
ID Number*
Device Expiration Date2004-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedU
Device Sequence No1
Device Event Key536855
ManufacturerFRESENIUS HEMOCARE, INC.
Manufacturer Address14715 NE 95TH ST., SUTE 100 REDMOND WA 98052 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. Life Threatening 2004-10-01

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