OtherMOS
MODEL #800239
Received Sep 11, 2006 · Event occurred Apr 19, 2006
Report 2183683-2006-00001 · MDR key 761355
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Blister(s)
- Bruise/Contusion
- Burn(s)
Narrative
Description of Event or Problem
MRI COIL, 800239. "TWO PATIENTS RECEIVED MILD SMALL RF BURN TO RIGHT THUMB AND BRUISE UNDER LEFT THUMB WITH SAME COIL. BURN WAS SMALL BLISTER, SMALLER THAN THE DIAMETER OF A PEA." SITE STARTED PADDING PATIENTS HANDS ON LATER SCANS AND HAS STATED THEY DID APPROX. 90 SCANS WITHOUT INCIDENT AFTERWARDS.
Additional Manufacturer Narrative
TO DATE, ANALYSIS OF INCIDENT AND POINTS TO MRI APPLICATION ERROR WHERE A LOOP WAS FORMED WITH PATIENT BODY LEADING TO SMALL RF BURN. NINETY SUBSEQUENT SCANS WITH PADDING WITH NO OTHER INCIDENTS SUPPORTS THIS. COIL IS BEING TESTED ADDITIONALLY BY MANF.