TOSHIBA
Received Apr 2, 2009 · Event occurred Mar 2, 2009
Report 2020563-2009-00005 · MDR key 1356321
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Burning Sensation
Narrative
Description of Event or Problem
MRI STUDY PERFORMED ON PT'S WRIST IN 2009. DURING THE STUDY, THE PT COMPLAINED OF A BURNING SENSATION ON HIS WRIST, BUT REQUESTED TO FINISH THE EXAM AS STATED BY THE TECHNOLOGIST.
Additional Manufacturer Narrative
DEVICE TO BE EVALUATED. RESULTS: RESULTS, ONCE THE DEVICE IS EVALUATED. CONCLUSIONS: DEVICE EVAL TO BE CONDUCTED. DURING THE SCAN THE PT WAS IN A SUPINE POSITION WITH THE AFFECTED WRIST DOWN BY THE SIDE. ACCORDING TO THE TECHNOLOGIST, IT WAS NOT UNTIL SERIES "E" T2 FSE AXIALS, THAT THE PT STARTED TO COMPLAIN ABOUT HAVING A BURNING SENSATION ON HIS WRIST. HE SQUEEZED THE PT BALL. THE TECHNOLOGIST ATTENDED TO THE PT, BUT DID NOT CHECK THE PT'S WRIST BECAUSE THE PT SAID HE WAS OKAY TO CONTINUE ON WITH THE STUDY WHICH WAS FINISHED. IN 2009, THE PT'S WIFE CALLED THE CUSTOMER AND STATED THAT HER HUSBAND HAD DEVELOPED A BLISTER ON THE WRIST WHICH THE MRI WAS PERFORMED. SHE ALSO INFORMED THE CUSTOMER THAT HE DID SEE THEIR PRIVATE PHYSICIAN REGARDING THE BLISTER WHICH AT THAT TIME SHOWED NO SIGNS OF INFECTION. THE COIL IS BEING RETURNED FOR EVAL.