MAUDE Adverse Event Report: NOVA ORTHOPEDIC & REHABILITATION APPLIANCE INC. (VIETNAM) FOLDING SIDE WALKER; WALKER, MECHANICAL

Model Number CH4060MD0219

Device Problem Collapse (1099)

Patient Problems Fall (1848); Balance Problems (4401)

Event Date 06/17/2022

Event Type  malfunction  

Event Description

Lost balance while entering home using a nova hemi walker rated for 250 lbs, when i shifted weight towards the hemi walked to try to regain balance a leg collapsed and i fell over the walker, i weigh around 178lbs at the moment.I don't seem to have sustained damage from the fall, but i have a fractured clavicle and the fall could have aggravated the injury.Fda safety report id # (b)(4).

• Brand Name: FOLDING SIDE WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): NOVA ORTHOPEDIC & REHABILITATION APPLIANCE INC. (VIETNAM)
• MDR Report Key: 14831295
• MDR Text Key: 294940460
• Report Number: MW5110530
• 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: 06/23/2022

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: Lay User/Patient
• Device Model Number: CH4060MD0219
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2022
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 81 KG