MAUDE Adverse Event Report: ROSCOE KNEE SCOOTER

Model Number ROS-KSB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/17/2016

Event Type  Injury  

Event Description

The end-user was prescribed and rented a knee scooter for use following an injury to his ankle.The end-user was walking into work from the parking lot with the use of the knee scooter, when the scooter hit a small crack in a portion of concrete.The knee scooter was unable to overcome the small elevation change, and stopped suddenly as he began moving forward.As a result, he flipped, and was severely and permanently injured.The user is reported as incurring hospital, doctor and medical expenses, as well as loss of wages.

Event Description

The item number was obtained for this report.Item number is ros-ksb.

• Brand Name: ROSCOE KNEE SCOOTER
• Type of Device: KNEE SCOOTER
• MDR Report Key: 5841464
• MDR Text Key: 50999822
• Report Number: 3005182235-2016-00020
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/02/2016,07/24/2019

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
• Device Model Number: ROS-KSB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2016
• Distributor Facility Aware Date: 07/11/2016
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention