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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CANON MEDICAL SYSEMS CORPORATION CANON MAGNETIC RESONANCE IMAGING SYSTEM

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CANON MEDICAL SYSEMS CORPORATION CANON MAGNETIC RESONANCE IMAGING SYSTEM Back to Search Results
Model Number MRT-3010
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Burning Sensation (2146)
Event Date 05/02/2022
Event Type  Injury  
Manufacturer Narrative
Patient was scanned on head/neck and spine rf coils for a thoracic study. After study completion, patient stated they felt a burning sensation in the posterior neck area during the scans. The tech asked why they didn't give feedback during the scan and the patient said they just wanted to get the scan over with. Later the patient contacted the site to report a burn on their body. Doctor (b)(6) reported he reviewed the area of the burn with the patient and no burn mark(s) was observed.
 
Event Description
Patient complained about burning sensation around posterior neck area after scan completion. Small metal artifact was identified posterior to patient on sagittal image scans after review of study.
 
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Brand NameCANON
Type of DeviceMAGNETIC RESONANCE IMAGING SYSTEM
Manufacturer (Section D)
CANON MEDICAL SYSEMS CORPORATION
1385 shimioshigami
otawara-shi,tochigi
324-8 550,
JA 324-8550,
Manufacturer (Section G)
CANON MEDICAL SYSEMS CORPORATION
1385 shimioshigami
otawara-shi,tochigi
324-8 550,
JA 324-8550,
Manufacturer Contact
paul biggins
2441 michelle drive
tustin, CA 92870
7147307500
MDR Report Key14714560
MDR Text Key294936712
Report Number2020563-2022-00004
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMRT-3010
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/16/2022 Patient Sequence Number: 1
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