InjuryMOS
SIEMENS SKYRA 3T
Received Dec 23, 2020 · Event occurred Dec 17, 2020
Report MW5098521 · MDR key 11071927
Device
Generic name
Coil, Magnetic Resonance, Specialty
Manufacturer
Siemens Shenzhen Magnetic Resonance Ltd.Model number
NACatalog number
NA
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
71 YR
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
PATIENT PRESENTED FOR MR SCAN ON (B)(6) 2020 OF THE RIGHT WRIST. SCAN COMPLETED WITHOUT INCIDENT AND PATIENT DISCHARGED. PATIENT RETURNED FOR SURGERY OF WRIST ON (B)(6) 2020 AND REPORTED THAT HER LEG WAS BURNED DURING MRI STUDY ON (B)(6) 2020. FDA SAFETY REPORT ID# (B)(4).