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 2006-11-02 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.

Event Text Entries

[522678] Pt developed chest pain and hypertension during her fourth prosorba treatment. Ekg negative. Oxygen saturation within normal limits. Nitro given. Upon arrival of paramedics symptoms had resolved, bp normal. Taken to er for evaluation. Fhc has been unable to obtain any add'l info from the physician in regard to this incident.
Patient Sequence No: 1, Text Type: D, B5


[7801873] This investigation is a clinical investigation only. Return of product not requested as evaluation of device after use not relevant to reported event. The device was used according to labeled indications and in the appropriate environment. Temporal relationship of the event and prosorba might suggest a contributory relationship.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3032792-2006-00016
MDR Report Key777728
Report Source05
Date Received2006-11-02
Date of Report2006-11-02
Date of Event2006-10-03
Report Date2006-11-02
Date Mfgr Received2006-10-03
Device Manufacturer Date2005-04-01
Date Added to Maude2006-11-08
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 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
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 Received2006-11-02
Model Number9798701
Catalog Number9798701
Lot NumberRDN001F
ID NumberNA
Device Expiration Date2006-10-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age18 MO
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key765506
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 2006-11-02

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