SENSE XL TORSO COIL 453567502284

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-08 for SENSE XL TORSO COIL 453567502284 manufactured by Philips Healthcare.

Event Text Entries

[4812629] Patient undergoing mri under anesthesia sustained second degree burns to bilateral thighs and 2 fingertips.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038004
MDR Report Key4055961
Date Received2014-08-08
Date of Report2014-08-07
Date of Event2014-07-31
Date Added to Maude2014-09-04
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 NameSENSE XL TORSO COIL
Generic NameTORSO COIL FOR MRI
Product CodeMOT
Date Received2014-08-08
Model Number453567502284
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS HEALTHCARE
Manufacturer AddressANDOVER 01810 01810


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-08-08

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