MAUDE Adverse Event Report: KOVAL INC., STEERABLE KNEE SCOOTER, ADULT WALKER W/WHEELS AND BASKET

Device Problems Crack (1135); Loose or Intermittent Connection (1371); Unstable (1667)

Patient Problem Ambulation Difficulties (2544)

Event Date 05/30/2017

Event Type  No Answer Provided  

Event Description

I purchased the koval knee scooter in (b)(4).In (b)(4) the back wheel came loose in a parking lot causing me off balance and stranded me with0ut a way to get to my car.Today while using it at home the frame cracked sending me off balance again and making me step down on my broken foot.I have emailed the company for a full refund and they are aware that i have notified you.This could have caused major injury to me and others.Document number: (b)(4), report number: (b)(4).Retailer: (b)(4), retailer state: (b)(4).Purchase date: (b)(6)2017.The product was not damaged before the incident.The product was not modified before the incident.Explanation: i sent them a note that i want an immediate refund or another one shipped fast.

• Brand Name: KOVAL INC., STEERABLE KNEE SCOOTER, ADULT WALKER W/WHEELS AND BASKET
• Type of Device: KNEE SCOOTER
• MDR Report Key: 6639619
• MDR Text Key: 77643168
• Report Number: MW5070397
• 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: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR