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MIST THERAPY SYSTEM

Received Oct 22, 2010 · Event occurred Sep 30, 2010

Report 3004580659-2010-00001 · MDR key 1881701

Device

Generic name

None

Manufacturer

Celleration, Inc.

Model number

CP-80004

Product problems

  • Human-Device Interface Problem

Patient

Not reported

  • Burn(s)
  • Pain

Narrative

Description of Event or Problem

TREATMENT NURSE WAS TREATING A PT AND SAID SHE TOUCHED THE TIP OF THE TRANSDUCER WITH THE PALM OF HER GLOVED RIGHT HAND BECAUSE SHE DIDN'T THINK SHE WAS SEEING ENOUGH SALINE MIST COMING OFF OF THE TRANSDUCER. SHE RECEIVED AN ACOUSTIC BURN, AND IMMEDIATELY REMOVED HER HAND. NO DAMAGE TO HER GLOVE OR SKIN. SHE SAID SHE REALIZED RIGHT AWAY THAT SHE WASN'T SUPPOSED TO TOUCH IT WHILE IT WAS ON. BESIDES THE INITIAL SENSATION ON HER HAND, SHE DID NOT HAVE ANY LONG LASTING PAIN OR ANY DAMAGE AS A RESULT OF THE INCIDENT.