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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCOMPASS THERAPUTIC SUPPORT SYSTEMS THERMOFLECT BLANKET, PATIENT, MRI

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ENCOMPASS THERAPUTIC SUPPORT SYSTEMS THERMOFLECT BLANKET, PATIENT, MRI Back to Search Results
Catalog Number 5100-400
Event Date 11/22/2009
Event Type  Injury  
Event Description

We scanned a patient with an mri while a hypothermia blanket with aluminum on one side. The blanket was mri conditional and it may be the reason our patient suffered a third degree burn. The patient will have to be grafted. The blanket is paper/blue on one side and aluminum/silver on the other. The silver side is intended to be placed away from the patient's skin. However, there is nothing on the blanket that would alert a provider that this should not come into contact with the patient's skin.

 
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Brand NameTHERMOFLECT
Type of DeviceBLANKET, PATIENT, MRI
Manufacturer (Section D)
ENCOMPASS THERAPUTIC SUPPORT SYSTEMS
500 n. central avenue
suite 900
glendale CA 91203
MDR Report Key1553108
Report Number1553108
Device Sequence Number1
Product CodeKME
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/04/2009
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received12/04/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator INVALID DATA
Device Catalogue Number5100-400
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/04/2009
Event Location HOSPITAL

Patient TREATMENT DATA
Date Received: 12/04/2009 Patient Sequence Number: 1
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