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

Model Number ROS-KSBG

Device Problem Component Falling (1105)

Patient Problems Fall (1848); Injury (2348)

Event Date 08/07/2017

Event Type  Injury  

Event Description

The customer put the knee scooter together at the store for the user.The user's wife said the handle bars were wobbly, and the customer told her that this was normal.The user's wife said the user fell off of the knee scooter when he was in the grass - the scooter fell to the right, and his foot went out, and he landed on his foot, injuring his achilles tendon on his right foot.He was already scheduled for surgery on his foot.The device involved with this event was returned to compass health brands and evaluation on 8/17/2017.The returned device was fully assembled, and found without any defects - the brakes functioned properly, and the over-steer stopper was not bent.No defects were found during the inpsection of this returned device - the customer's complaint could not be duplicated from a review of the returned device.

• 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: 6840179
• MDR Text Key: 84622299
• Report Number: 3012316249-2017-00113
• 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: 09/01/2017

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-KSBG
• Device Catalogue Number: ROS-KSBG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2017
• Distributor Facility Aware Date: 08/07/2017
• Event Location: Home
• Date Report to Manufacturer: 09/01/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR