LIQUICHEK URINALYSIS CONTROL 420

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2003-06-13 for LIQUICHEK URINALYSIS CONTROL 420 manufactured by Bio-rad Laboratories.

Event Text Entries

[325691] A lab tech came into contact with the product when the technician's finger was stuck by a needle. The lab tech used the syringe to remove the control from the vial.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2016706-2003-00002
MDR Report Key466589
Report Source01,05
Date Received2003-06-13
Date of Report2003-05-15
Date of Event2003-05-13
Date Mfgr Received2003-05-13
Device Manufacturer Date2001-10-01
Date Added to Maude2003-06-20
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 Location0
Manufacturer ContactYVETTE LOYD SENIOR SPECIALIST
Manufacturer Street9500 JERONIMO RD
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9495981200
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameLIQUICHEK URINALYSIS CONTROL
Generic NameQUALITY CONTROL MATERIAL
Product CodeJJT
Date Received2003-06-13
Model NumberNA
Catalog Number420
Lot Number61160
ID NumberNA
Device Expiration Date2004-04-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key455534
ManufacturerBIO-RAD LABORATORIES
Manufacturer Address9500 JERONIMO RD IRVINE CA 926182017 US
Baseline Brand NameLIQUICHEK URINALYSIS CONTROL
Baseline Generic NameQUALITY CONTROL MATERIAL
Baseline Model NoNA
Baseline Catalog No420
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-06-13

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