MAX TRAX WALKER
Received Apr 1, 2014 · Event occurred Feb 27, 2014
Report 9616086-2014-00009 · MDR key 3735657
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Cellulitis
Narrative
Description of Event or Problem
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.