MAUDE Adverse Event Report: TAICANG JINGQUAN MEDICAL DRIVE; WALKER

Model Number 796

Device Problem Mechanical Jam (2983)

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

Event Date 01/21/2015

Event Type  Injury  

Event Description

(b)(4) was the initial importer of the device which is a walker.(b)(4) was first notified of the incident by a legal notice.End user was exiting his classroom using the device and went over transition in the flooring.He reported that the wheels jammed and he fell.Drive was initially unaware of the injuries sustained.We have since discovered that the end-user fractured his tibia/fibia during the fall.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): TAICANG JINGQUAN MEDICAL; #168 shenxing rd; liuijaguan town; taicang, jiangsu 21543 3; CH 215433
• MDR Report Key: 7405062
• MDR Text Key: 104660040
• Report Number: 2438477-2018-00014
• 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: Attorney
• Type of Report: Initial
• Report Date: 04/06/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 796
• 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: 04/06/2018
• Distributor Facility Aware Date: 09/11/2017
• Device Age: 7 MO
• Event Location: Other
• Date Report to Manufacturer: 04/09/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other