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

Model Number ROS-KSB

Device Problem Use of Device Problem (1670)

Patient Problems Abrasion (1689); Fracture, Arm (2351)

Event Date 08/25/2019

Event Type  Injury  

Event Description

The end-user was at an outlet mall and when she was leaving the front wheels of the device got caught in the crevice of the sidewalk and she was thrown from the scooter.She came down on her left wrist and it was fractured.She also has some scrapes on her left knee.The end user stated the device was not regularly inspected for damage/wear and tear, she assumed the rental store did that.Instruction manual attached.On page 6 the 6th bulletin down states "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." the 7th bulletin down in red capital letters states "always inspect scooter prior to riding." on page 7 the first 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 accidents." the third bulletin down states "move slowly so that you can stop safely using your pushing foot." 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 states in bold red capital letters "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.".

Event Description

The device was returned for inspection.This unit appears to have nothing wrong with it.All the components are in place and work properly.Chb was unable to confirm the customers complaint.

• 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: 9081996
• MDR Text Key: 163221092
• Report Number: 3012316249-2019-00024
• 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: 09/18/2019,08/06/2020

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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2019
• Distributor Facility Aware Date: 08/06/2020
• Event Location: Other
• Date Report to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 84