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

Model Number ROS-KSB

Device Problem Break (1069)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Disability (2371)

Event Date 12/03/2016

Event Type  Injury  

Event Description

Per the user, she had foot fusion surgery (b)(6) 2016.She is a house trainer, and the surgery was necessary for work.She states that she is very conscientious during convalescence, and she followed every recommendation.En route to the bathroom 48 hours after (foot) surgery, the handle bars of the rollator flew off, and the user is reported as holding on, crashing to the floor, shattering her hip and femur.She is reported as having not yet recovered.The user states that this has ruined her career and her life - she had to give up her farm.She had a professional put it together.The user also stated, "i am a very fit, strong person, but my trusting this device ruined my life.I am a huge contributor in my teaching both health and compromised kids to ride.And now, i am disabled." on (b)(6) 2017, the user followed up with compass health brands.It is reported in this communication that the user will undergo 10 months of rehab for her broken bones, primarily her femur, hip, and shoulder."i hope you understand that i am understating the severity of my injuries, all a result of having elective foot surgery to enable me to be a better teacher." (prior to event occurring on rollator) ".The foot surgery's convalescence was to be 4 weeks.And here we are in late (b)(6) and i must have medical care daily: 3 days for pt and two for learning methods of coping, learning new approaches to daily tasks.And weekly physician check ups." no further information regarding this event has been obtained.

Event Description

Type of device involved with event updated; item number updated; supplier updated; user weight updated; date of event updated.Customer also proivded the following additional information: user had foot surgery & reported that a professional had put the device together.One day after foot surgery, at a slow pace, the steering mechanism on the device (knee scooter) became detached - the user reported that she held on, crashing to the hardwood floor, breaking/shattering both her hip and femur.She reported that she lost her job, had to move from her home, and is now in a desperate financial state.The user goes on to state that the surgery was (b)(6) 2016, and the hip and femur injury occurred on (b)(6) 2016 - she reports that she is still disabled & has spent months in rehab.

• Brand Name: ROSCOE
• Type of Device: KNEE SCOOTER
• Manufacturer (Section D): TAICANG JINGQUAN METAL PRODUCTS CO., LTD.; no. 168 zhen-xing road, liujia; taicang jiangsu, 21543 3; CH 215433
• MDR Report Key: 6997401
• MDR Text Key: 90939245
• Report Number: 3012316249-2017-00129
• 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,Followup
• Report Date: 02/01/2018

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
• Device Catalogue Number: ROS-KSB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2018
• Distributor Facility Aware Date: 01/24/2018
• Event Location: Home
• Date Report to Manufacturer: 02/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 48