SIEMENS SYMPHONY 1.5 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-30 for SIEMENS SYMPHONY 1.5 NA manufactured by Siemens.

Event Text Entries

[27459716] After patient completed scan - complaint of a burning/tingling sensation on right lower quadrant area of abdomen. Type of scan is lumbar spine with enhancement utilizing of omniscan.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5124623
MDR Report Key5124623
Date Received2004-07-30
Date of Report2004-07-14
Date of Event2004-06-21
Date Facility Aware2004-06-21
Report Date2004-07-14
Date Reported to Mfgr2004-07-14
Date Added to Maude2015-10-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSIEMENS SYMPHONY 1.5
Generic NameMRI
Product CodeMRI
Date Received2004-07-30
Model NumberSYMPHONY 1.5
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age4 YR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS
Manufacturer AddressINDEPENDENCE OH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-07-30

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