CANON
Received Jan 5, 2026 · Event occurred Nov 10, 2025
Report 2020563-2025-00012 · MDR key 23960023
Device
Product problems
- Patient Device Interaction Problem
Patient
NA · Female
- Burn(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A SCAN USING THE 16CH FLEX LARGE COIL ON (B)(6) 2025, A PATIENT EXPERIENCED A SECOND-DEGREE KNEE BURN. THE PATIENT WAS REPORTEDLY WEARING SWEATPANTS AT THE TIME OF THE SCAN AND DID NOT COMPLAIN DURING OR AFTER THE SCAN. THE FACILITY DELETED THE CASE FROM THE SCANNER, BUT AN IMAGE REVIEW ON PACS SHOWED NO METALLIC ARTIFACTS IN THE IMAGES FROM EITHER METAL OR LOTIONS. THE FACILITY REPORTED THE BURN COMPLAINT WAS MADE TO THEM ON (B)(6) 2025. ON (B)(6) 2025 THE PATIENT WENT TO A VCU CLINIC AND THE INJURY WAS DIAGNOSED AS A 2ND DEGREE, RF INDUCED BURN. THE BURN WAS REPORTEDLY TREATED BY AN ORTHOPEDIC DOCTOR AS AN ANTERIOR MEDIAL BLISTER.