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 Contusion (1787); Fall (1848)

Event Type  Injury  

Event Description

The end-user's leg slipped off the device and he fell forward and the handle jammed his pancreas, which he said was injured.

Event Description

End-user's address provided.

• 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: 9171865
• MDR Text Key: 161835323
• Report Number: 3012316249-2019-00032
• 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: 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: 53 MO
• Date Report to Manufacturer: 10/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other