INVIVO CORP DS 3T HEAD COIL
Received Jul 26, 2019 · Event occurred Jul 12, 2019
Report MW5088412 · MDR key 8837598
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
37 YR
- Itching Sensation
- Burning Sensation
- Itching Sensation
- Burning Sensation
Narrative
Description of Event or Problem
PT HAD POSSIBLE BURN ON BACK OF NECK AFTER 3T BRAIN EXAM WITHOUT IV CONTRAST. PERFORMED ROUTINE BRAIN EXAM WITHOUT IV CONTRAST IN 3T SCANNER. AFTER STUDY WAS COMPLETE PT COMPLAINED OF A BURNING/ ITCHING MID BACK C7-T1 AREA. PT WAS PROPERLY SCREENED, AND GOWNED AND HAD NO OBJECTS ON HER THAT WOULD BE CONTRAINDICATED TO MRI. PT WAS GIVEN EMERGENT SQUEEZE BULB BUT DID NOT USE IT DURING THE EXAM. SPOKE WITH THE PT AFTERWARDS, SHE DENIES ANY ALLERGIES, WAS NOT SWEATING DURING THE EXAM AND HAS NO OTHER AREAS OF ANY PAIN / ITCHINESS. DRS (B)(6) CAME TO MRI TO TALK WITH THE PT AND EXAMINE HER. THEY ADVISED HER TO GO TO THE ED IF THE AREA OF INTEREST BECOMES MORE PAINFUL OR RED. DR (B)(6) IS MAKING A NOTE IN THE CHART AND WE WILL MOVE ON CREATING A MIDAS AND DOCUMENT ALL IN CHART.