inforMED
MalfunctionMOS

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Received Feb 20, 2013 · Event occurred Jan 16, 2013

Report 3001504 · MDR key 3001504

Device

Generic name

Coil, Magnetic Resonance, Specialty

Model number

*

Catalog number

400105280200

Lot number

*

Product problems

  • Patient-Device Incompatibility

Patient

31 YR

  • Hypersensitivity/Allergic reaction
  • Burning Sensation
  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

BURNING SENSATION AROUND NECK OCCURRED IN MRI. SINCE THAT TIME, WHEN THE PATIENT'S NECK BRACE WAS TAKEN OFF BLISTERS HAD FORMED ON BOTH SIDES OF NECK WHERE THE PATIENT FELT THE BURNING. THE MRI TECH WAS INTERVIEWED. PRIOR TO THE MRI, THE PATIENT DID NOT COMPLAIN OF BURNING AND ALL METAL WAS REMOVED DURING SCREENING. PT HAS SKIN HYPERSENSITIVITY AND MAY HAVE HAD A REACTION TO THE RADIOLUCENT SPONGES AROUND MRI COIL. RADIOLOGISTS REVIEWED IMAGES SHOWING NO ARTIFACT. WOUND CARE IS ADDRESSING THE SITE. THE PATIENT OPENLY ADMITTED TO HAVING SENSITIVE SKIN. THE RIGHT SIDE IS WORSE THAN THE LEFT SIDE.