Per 21 cfr 803, an mdr reportable event, complaint received from patient that alleges "patient noticed, a small red area on my left lateral portion of my foot less than the size of a dime.But tuesday, it was the size of a quarter and i began to be concerned.I wore another boot from my prior condition and saw my doctor.At that time, the red area was the size of a 50 cent piece and heading towards my toes.She made the diagnosis cellulitis.It spread rapidly through out my entire lateral and upper foot and toes." questionnaire not received from clinician and/or patient.Product no returned to manufacturer for review.No indication device caused or contributed to the event.
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