MAUDE Adverse Event Report: DJO, LLC MAXTRAX WALKER

Device Problems Detachment Of Device Component (1104); Fail-Safe Design Failure (1222)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Pt complained that the device is not safe for walking and balance, and there is the risk for falls.Also the velcro fasteners do come apart.

• Brand Name: MAXTRAX WALKER
• Type of Device: WALKER
• Manufacturer (Section D): DJO, LLC; 1430 decision st; vista CA 92081
• MDR Report Key: 4045038
• MDR Text Key: 4728944
• Report Number: MW5037922
• Device Sequence Number: 1
• Product Code: ITJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2014
• Patient Sequence Number: 1
• Patient Weight: 57