LIQUID - STAT PHOSPHORUS REAGENT 467868

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-04-03 for LIQUID - STAT PHOSPHORUS REAGENT 467868 manufactured by Beckman Coulter Inc..

Event Text Entries

[21977461] Service was not dispatched. No additional information was provided.
Patient Sequence No: 1, Text Type: N, H10


[22094304] Beckman coulter inc. (bci) (b)(4) facility reported receiving damaged phosphorous reagent containers. No injury or operator exposure was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2050012-2011-00821
MDR Report Key2037210
Report Source01,06
Date Received2011-04-03
Date of Report2011-03-03
Date of Event2011-03-03
Date Mfgr Received2011-03-03
Date Added to Maude2012-02-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. NORA ZEROUNIAN
Manufacturer Street250 KRAEMER BLVD.
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal92821
Manufacturer Phone7149613634
Manufacturer G1BECKMAN COULTER INC.
Manufacturer Street250 S. KRAEMER BLVD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal Code92821
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIQUID - STAT PHOSPHORUS REAGENT
Generic NamePHOSPHORUS ANALYSIS PRODUCT
Product CodeCEO
Date Received2011-04-03
Model NumberPHOSPHORUS REAGENT
Catalog Number467868
Lot NumberM012436
ID NumberN/A
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER INC.
Manufacturer Address250 S. KRAEMER BLVD BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2011-04-03

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