PROSORBA 9007031 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-15 for PROSORBA 9007031 * manufactured by Fresenius Hemocare, Inc..

Event Text Entries

[15484856] Patient with worsening anemia, presumably from bleeding gastric ulcer. By treatment #3 patient's "h/h" had dropped to 9. 9/29. 9. After this treatment patient's speech became slurred and patient developed left hemiparesis. Diagnosed with cerebrovascular accident and discharged after 5 days with symptoms resolving. This event occurred in 2000 but was not reported. It was "mentioned" to a sales rep 9 months later, confirmed by physician the next month.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3032792-2002-00003
MDR Report Key388697
Date Received2002-04-15
Date of Report2002-04-12
Date of Event2000-03-01
Date Facility Aware2001-01-04
Device Manufacturer Date1999-08-01
Date Added to Maude2002-04-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTOM TROTTER
Manufacturer Street6675 - 185TH AVE. NE SUITE 100
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal98052
Manufacturer Phone4254971197
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROSORBA
Generic NameIMMUNOADSORPTION COLUMN
Product CodeFLD
Date Received2002-04-15
Model Number9007031
Catalog Number*
Lot Number081899H
ID NumberPMA P850020
Device Expiration Date2000-08-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedU
Device Sequence No1
Device Event Key377746
ManufacturerFRESENIUS HEMOCARE, INC.
Manufacturer Address6675 - 185TH AVE. NE SUITE 100 REDMOND WA 98052 US
Baseline Brand NamePROSORBA
Baseline Generic NameIMMUNOADSORPTION COLUMN
Baseline Model No9007031
Baseline Catalog No*
Baseline IDPMA P850020


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2002-04-15

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