MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2006-03-30 for manufactured by .

MAUDE Entry Details

Report Number9616240-2006-00262
MDR Report Key697495
Report Source05,06,07
Date Received2006-03-30
Date of Event2006-02-27
Date Mfgr Received2006-02-28
Device Manufacturer Date2003-04-01
Date Added to Maude2006-04-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactFRANCESCO BARDELLI
Manufacturer StreetVIA MODENESE, 66
Manufacturer CityMEDOLLA (MO) I-41036
Manufacturer CountryIT
Manufacturer PostalI-41036
Manufacturer Phone53550111
Manufacturer G1GAMBRO DASCO
Manufacturer StreetVIA MODENESE, 66
Manufacturer CityMEDOLLA (MO) I-41036
Manufacturer CountryIT
Manufacturer Postal CodeI-41036
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeFIF
Date Received2006-03-30
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key683750
Baseline Brand NamePRISMA CONTROL UNIT
Baseline Generic NameINTENSIVE CARE HEMODIALYSIS
Baseline Model NoPRISMA
Baseline Catalog No018080100
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2006-03-30

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