ADSORBA 115263

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 2019-07-01 for ADSORBA 115263 manufactured by Baxter Healthcare - Hechingen Baden Dialyzer.

MAUDE Entry Details

Report Number9611369-2019-00089
MDR Report Key8750426
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-01
Date of Report2019-07-19
Date of Event2019-06-05
Date Mfgr Received2019-06-25
Date Added to Maude2019-07-01
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 - HECHINGEN BADEN DIALYZER
Manufacturer StreetHOLGER - CRAFOORD - STRASSE 26
Manufacturer CityHECHINGEN D-72379
Manufacturer CountryGM
Manufacturer Postal CodeD-72379
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADSORBA
Generic NameAPPARATUS, HEMOPERFUSION, SORBENT
Product CodeFLD
Date Received2019-07-01
Model NumberNA
Catalog Number115263
Lot Number7-660
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
Manufacturer AddressHECHINGEN


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-01

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