MAUDE Adverse Event Report: DJO, LLC MAX TRAX WALKER; WALKER BOOT

Model Number 79-95495

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cellulitis (1768)

Event Date 02/27/2014

Event Type  Injury  

Event Description

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.

• Brand Name: MAX TRAX WALKER
• Type of Device: WALKER BOOT
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana b.c. 2224 4; MX 22244
• Manufacturer Contact: 1430 decision street; vista, CA 92081 ; 7607271280
• MDR Report Key: 3735657
• MDR Text Key: 4227325
• Report Number: 9616086-2014-00009
• Device Sequence Number: 1
• Product Code: IPG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 79-95495
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other