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 2005-11-15 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.

Event Text Entries

[424512] An ra patient was admitted to the hospital after her 10th prosorba treatment with chest pain and hypotension. She later underwent an angioplasty. She has a history of coronary artery disease but neither the rheumatologist or apheresis personnel were aware of any details regarding it. She had recently been taken off an ace inhibitor due to prosorba treatments. Her rheumatologist was unable to obtain any records from the hospital regarding her treatment for this adverse event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3032792-2005-00019
MDR Report Key646533
Report Source05
Date Received2005-11-15
Date of Report2005-11-15
Date of Event2005-10-14
Report Date2005-11-05
Date Mfgr Received2005-10-18
Device Manufacturer Date2005-01-01
Date Added to Maude2005-11-18
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 ContactJOSHUA LASKER
Manufacturer Street14715 NE 95TH ST, STE 100
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal98052
Manufacturer Phone4252422154
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 Received2005-11-15
Model Number9798701
Catalog Number9798701
Lot NumberRAN002C
ID NumberNA
Device Expiration Date2006-07-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age9 MO
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key636040
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 2005-11-15

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