EM2400 LOAD CELL MODULE 2400L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-19 for EM2400 LOAD CELL MODULE 2400L manufactured by Baxter Healthcare Corporation.

MAUDE Entry Details

Report Number1416980-2019-06417
MDR Report Key9341532
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-19
Date of Report2019-11-19
Date of Event2019-10-25
Date Mfgr Received2019-10-25
Date Added to Maude2019-11-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1ECM - ENGLEWOOD
Manufacturer Street14445 GRASSLANDS DR
Manufacturer CityENGLEWOOD CO 80112
Manufacturer CountryUS
Manufacturer Postal Code80112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEM2400 LOAD CELL MODULE
Generic NameSYSTEM/DEVICE, PHARMACY COMPOUNDING
Product CodeNEP
Date Received2019-11-19
Returned To Mfg2019-10-28
Model NumberNA
Catalog Number2400L
Lot NumberNA
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-19

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