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

Model Number ROS-KSB

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Injury (2348)

Event Date 04/29/2017

Event Type  Injury  

Event Description

Consumer was using the scooter after surgery for a repair to a jones fracture.The back wheel suddenly came off sending him head first over the front of it.Consumer landed on his head and neck, resulting in serious injuries that his doctor believes will require either a fusion or disc replacement to repair.

Event Description

09/15/2018 update to event: photos have been provided; the axel of the knee scooter itself was in rough shape (gouged), and the internal thread appears pretty stripped out.The user had surgery to repair a jones fracture to his left foot due to an injury he sustained.After surgery, the knee scooter was ordered by the worker's comp carrier (due to sustained jones fracture injury) and delivered to the user's home.The worker's comp carrier does not know if the user was provided any type of training on how to use the device.About 10 days after surgery, the user was at home using the knee scotoer on hard wood floor, when one of the back wheels came off, causing him to be thrown forward, landing on his head and neck.The user's wife took him to the er shortly after the incident, where testing was done & we was then referred to a neurologist.Due to the user landing on his head & neck, he received serious injuries that his doctor believes will require either a fusion or disc replacement to repair.The user is still being treated for the worker's comp claim & the attorney's notes do indicate that he is going to have another surgery (for the worker's comp claim).Attorney notes are unclear if the user has been seen by the neurologist & they have not obtained complete medical records, so they are unsure what treatment has been received for the worker's comp incident.The user is still in posession of the knee scooter, and indicated that will make it available for inspection at a later date.The user's weight was updated as "under 250lbs.".

• Brand Name: ROSCOE MEDICAL
• 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: 7175417
• MDR Text Key: 96752691
• Report Number: 3012316249-2018-00001
• 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: 09/11/2018

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: 09/11/2018
• Distributor Facility Aware Date: 09/15/2018
• Date Report to Manufacturer: 09/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 113