MAUDE Adverse Event Report: TAICANG JINGQUAN METAL PRODUCTS CO., LTD ROSCOE; KNEE SCOOTER

Model Number ROS-KSB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Loss of Range of Motion (2032); Patient Problem/Medical Problem (2688)

Event Date 12/14/2016

Event Type  Injury  

Event Description

The end-user fell in the gap between the seat and the handlebars and his leg got hooked.He went over the handlebars and tore the rotator cuffs in both arms.He says in general, when you go to move across carpet or something uneven, it tips easily.He hasn't had the shoulder repaired.He had an mri of his shoulders in (b)(6) 2017.Manual.On page 5 under "movement" 4th and 5th bulletins down state "move slowly so that you can stop safely using your pushing foot.The hand brake may be used if needed but is primarily designed to maintain a stopped stance." page 6 under "warnings" 4th bulletin down states "injury may result if seat knee platform adjustment instructions are not followed." the 6th bulletin states "the scooter is intended for use with a single person in place on the scooter.All wheels must be in contact with the floor/ground at all times.Failure to maintain this could result in improper balance of the scooter and cause injury or damage." page 7, 1st bulletin states "be aware of your surroundings when operating the scooter.Look for hazards and avoid them.Avoid streets and surfaces with water, sand, gravel, dirt, leaves, and other debris.Wet, slick, uneven and/or rough surfaces may impair traction and contribute to possible accident.The 6th bulletin down states "use caution when moving from carpeted to hard surface floors or cracks/separations in walkway surfaces; avoid sharp bumps, drainage grates, and sudden surface changes.Scooter may abruptly stop (i.E.Moving from a curb to the street and back onto the sidewalk)." the bottom of page 7 in bold red letters states "failure to use common sense and heed the above warnings further increases risk of serious injury.Use at your own risk and with appropriate and serious attention to safe operation.Use caution.".

• Brand Name: ROSCOE
• Type of Device: KNEE SCOOTER
• Manufacturer (Section D): TAICANG JINGQUAN METAL PRODUCTS CO., LTD; no. 168 zhen-xing road; liujiaguan town; taicang jiangsu, 21543 3; CH 215433
• MDR Report Key: 9172027
• MDR Text Key: 170029750
• Report Number: 3012316249-2019-00033
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2019

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?: No
• 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: 10/09/2019
• Distributor Facility Aware Date: 09/20/2019
• Device Age: 54 MO
• Date Report to Manufacturer: 10/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other