WA96 PLUS GENERIC B1018-284

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 2019-08-08 for WA96 PLUS GENERIC B1018-284 manufactured by Beckman Coulter.

MAUDE Entry Details

Report Number2919016-2019-01001
MDR Report Key8876535
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-08-08
Date of Report2019-08-08
Date of Event2018-05-29
Date Facility Aware2018-05-29
Date Mfgr Received2018-05-29
Device Manufacturer Date2016-03-10
Date Added to Maude2019-08-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. HELLEN FOX
Manufacturer Street1584 ENTERPRISE BLVD
Manufacturer CityWEST SACRAMENTO CA 95691
Manufacturer CountryUS
Manufacturer Postal95691
Manufacturer Phone9163742313
Manufacturer G1BECKMAN COULTER
Manufacturer Street2040 ENTERPRISE BLVD
Manufacturer CityWEST SACRAMENTO CA 95691
Manufacturer CountryUS
Manufacturer Postal Code95691
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWA96 PLUS GENERIC
Generic NameWA96 PLUS GENERIC
Product CodeLRG
Date Received2019-08-08
Model NumberB1018-284
Catalog NumberB1018-284
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER
Manufacturer Address2040 ENTERPRISE BLVD WEST SACRAMENTO CA 95691 US 95691


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-08-08

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