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 2006-06-01 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.

Event Text Entries

[15702863] Patient developed hive-like rash, chest tightness and sob 4 hours after 6th prosorba. She was admitted to hospital and treated for anaphylaxis. She was administered iv steroids, epinephrine and benadryl and admitted to the icu overnight for observation. Symptoms resolved and patient was discharged the next day. Fhc's medical consultant, a rheumatologist, described this event as an immune complex mediated "anaphylaxoid" reaction due to cryoglobulin spikes and complement activation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3032792-2006-00005
MDR Report Key722406
Report Source05
Date Received2006-06-01
Date of Report2006-06-01
Date of Event2006-05-03
Date Facility Aware2006-05-04
Report Date2006-06-01
Date Mfgr Received2006-05-04
Device Manufacturer Date2005-07-01
Date Added to Maude2006-06-06
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. SUITE 100
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal98052
Manufacturer Phone4252422154
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROSORBA COLUMN
Generic NameIMMUNOADSORPTION COLUMN
Product CodeLQQ
Date Received2006-06-01
Model Number9798701
Catalog Number9798701
Lot NumberRGN001A
ID NumberNA
Device Expiration Date2007-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age10 MO
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key711473
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 2006-06-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.