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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO INVIVO SENSE XL TORSO MRI COIL
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INVIVO INVIVO SENSE XL TORSO MRI COIL Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)
Event Date 04/07/2014
Event Type  Injury  
Event Description
Philips mri 1.5t achieva scanner was utilized on pt for scan of lower extremities.During the scan the pt expressed feeling heat or burning feeling of his left upper medial thigh.Upon technician assessment no burn was assessed.After completion of the scan, the pt indicated to the technician, the pt now had 2 burns.The technician reassessed the pt and confirmed the presence of the 2 quarter sized burns.The pt was treated for second degree burns in the ed of our facility.The mri coil was taken out of service and our biomed staff notified philips.The coil is an invivo sense xl torso coil.Our risk management took pictures of the coil and we plan to provide the coil back to philips for failure mode testing.Diagnosis or reason for use: appliance is necessary to create image on mri scan.Event abated after use stopped or dose reduced: yes.
 
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Brand Name
INVIVO SENSE XL TORSO MRI COIL
Type of Device
INVIVO SENSE XL TORSO MRI COIL
Manufacturer (Section D)
INVIVO
NL 
MDR Report Key3757108
MDR Text Key18368714
Report NumberMW5035662
Device Sequence Number1
Product Code MOS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Other Device ID Number453567502284
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age66 YR
Patient Weight86
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