AERA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-27 for AERA manufactured by Siemens.

Event Text Entries

[4996208] During a mri scan on a 1. 5 t siemens aera scanner, the patient having a pelvic mri received a burn on both things on the inside due to the skin touching. Three cm area of redness not requiring medical attention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038883
MDR Report Key4217279
Date Received2014-10-27
Date of Report2014-10-27
Date of Event2014-10-22
Date Added to Maude2014-11-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAERA
Generic NameMRI
Product CodeMRI
Date Received2014-10-27
Model NumberAERA
ID Number9219
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS


Patients

Patient NumberTreatmentOutcomeDate
10 2014-10-27

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