MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 1998-12-22 for manufactured by .

MAUDE Entry Details

Report Number2023337-1998-00001
MDR Report Key204224
Report Source04,05,06
Date Received1998-12-22
Date of Event1998-10-09
Date Mfgr Received1998-10-23
Date Added to Maude1999-01-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeFOA
Date Received1998-12-22
Device Eval'ed by MfgrN
Implant FlagN
Device Sequence No1
Device Event Key198356
Baseline Brand NameSIGMA I.V. POLE
Baseline Generic NameI.V. POLE
Baseline Model NoUNK
Baseline Catalog NoUNK
Baseline ID46260-1979


Patients

Patient NumberTreatmentOutcomeDate
10 1998-12-22

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