MARS 800473

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-27 for MARS 800473 manufactured by Baxter Healthcare - Rostock.

MAUDE Entry Details

Report Number3007697864-2019-00002
MDR Report Key9383275
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-27
Date of Report2019-11-27
Date of Event2019-10-16
Date Mfgr Received2019-10-31
Date Added to Maude2019-11-27
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 Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - ROSTOCK
Manufacturer StreetFRIEDRICH-BARNEWITZ-STRASSE 4
Manufacturer CityROSTOCK 18119
Manufacturer CountryGM
Manufacturer Postal Code18119
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMARS
Generic NameAPPARATUS, HEMOPERFUSION, SORBENT
Product CodeFLD
Date Received2019-11-27
Returned To Mfg2019-11-14
Model NumberNA
Catalog Number800473
Lot Number0000022989
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - ROSTOCK
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-27

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