VYSIS LSI PML/RARA DUAL COLOR/DUAL FUSION PROBES 05J70-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-06-21 for VYSIS LSI PML/RARA DUAL COLOR/DUAL FUSION PROBES 05J70-01 manufactured by Abbott Molecular, Inc..

MAUDE Entry Details

Report Number3005248192-2019-00005
MDR Report Key8724041
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-06-21
Date of Report2019-07-01
Date of Event2019-06-07
Date Mfgr Received2019-06-21
Device Manufacturer Date2019-02-02
Date Added to Maude2019-06-21
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 ContactMR. JOE HUTSON
Manufacturer Street1300 E. TOUHY AVE.
Manufacturer CityDES PLAINES IL 600183315
Manufacturer CountryUS
Manufacturer Postal600183315
Manufacturer Phone2243617619
Manufacturer G1ABBOTT MOLECULAR, INC.
Manufacturer Street1300 E. TOUHY AVE.
Manufacturer CityDES PLAINES IL 600183315
Manufacturer CountryUS
Manufacturer Postal Code600183315
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVYSIS LSI PML/RARA DUAL COLOR/DUAL FUSION PROBES
Generic NameREAGENTS, SPECIFIC, ANALYTE
Product CodeMVU
Date Received2019-06-21
Catalog Number05J70-01
Lot Number492875
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MOLECULAR, INC.
Manufacturer Address1300 E. TOUHY AVE. DES PLAINES IL 600183315 US 600183315


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-21

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