InjuryMOS
8CH SHOULDER COIL 1, 5T IRF
Received Apr 16, 2013 · Event occurred Feb 28, 2013
Report 1056069-2013-00001 · MDR key 3069619
Device
Product problems
- Insufficient Device Problem Information
Patient
47 YR
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
DURING A SCANNING PROCESS, THE PATIENT WAS POSITIONED SUPINE HEAD FIRST IN A PHILIPS INGENIA 1.5T SYSTEM. A SHOULDER COIL 8CH 1.5T WAS USED TO PERFORM A SHOULDER EXAMINATION. AFTER THE EXAMINATION, A SECOND DEGREE BLISTER OF 3 BY 4 CENTIMETER WAS OBSERVED ON THE RIGHT LOWER ARM.
Additional Manufacturer Narrative
(B)(4). EVALUATION METHOD, RESULTS, CONCLUSIONS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.