MAUDE Adverse Event Report: LIFESTYLE MOBILITY AIDS, INC. KNEE WALKER; WALKER, MECHANICAL

Device Problems Break (1069); Device Fell (4014)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 05/14/2019

Event Type  Injury  

Event Description

I had my right ankle fused on (b)(6) 2019 and was using a knee walker.I came around the corner to go into my kitchen and the back wheel fell off my scooter.My right leg slammed down onto the floor, due to extreme pain i had to go to the er twice.I had an ultrasound of my leg which was negative.Blood was taken and all normal.On (b)(6) 2019 i was seen in my surgeon's office and x-ray was taken, it showed six fractures in my tibia and fibula.I had surgery on (b)(6) 2019 to place plates and redo the ankle fusion.It was found that i had osteomyelitis.I went to rehab (b)(6) 2019 and was released on (b)(6) 2019.I was on iv antibiotics for six weeks.Fda safety report id# (b)(4).

• Brand Name: KNEE WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): LIFESTYLE MOBILITY AIDS, INC.
• MDR Report Key: 9197085
• MDR Text Key: 162680419
• Report Number: MW5090405
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 90