MAUDE Adverse Event Report: NOVA KNEE SCOOTER

Model Number TKW-12

Device Problems Unstable (1667); Material Integrity Problem (2978)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 11/15/2016

Event Type  Other  

Event Description

A rented a nova medical knee scooter after my foot surgery.It is very wobbly and unsteady.The handle bar grips are made of plastic.I fell off the scooter while riding it outside to the mailbox.Since the handle grips are not metal, one broke during my fall.(they should be metal to avoid this) i landed on my knee - on top of the broken piece of extremely sharp plastic.The result was a 5 inch gash that required 9 stitches.This scooter is poorly made.It is not stable and the plastic components should be metal, so no fragments occur if dropped or someone falls.Please investigate this product so the same doesn't happen to others.Incident location: (b)(6), this is my home address location.Injury, emergency department treatment received.Purchase date: (b)(6) 2016.Document number: (b)(4).Report number: (b)(4).

• Brand Name: KNEE SCOOTER
• Type of Device: KNEE SCOOTER
• Manufacturer (Section D): NOVA; 1470 beachey place; carson CA 90746
• MDR Report Key: 6157922
• MDR Text Key: 62192168
• Report Number: MW5066610
• 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: 11/27/2016

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?: No
• Device Operator: No Information
• Device Model Number: TKW-12
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR