MAUDE Adverse Event Report: HL CORP. (SHENZHEN) DRIVE; WALKER

Model Number	990X
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Bone Fracture(s) (1870)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a knee walker.We have not received the product return at this time.It is with the service provider who rented this device.Consumer rented the device for use on her trip abroad.She could not put weight on her foot while it healed.While packing she pushed off with her good foot.The knee walker stopped moving as the wheels went out from underneath her.The top snapped off the device.The user fell forward and hit her collarbone.Xrays were taken by a doctor.She reported that she had 2 fractures of her right foot, a sprained knee and a bruised collarbone.She is looking for compensation.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): HL CORP. (SHENZHEN); the 3rd industrial park; bitou village, song gang town; baoan district, shenzhen, 51810 5; CH 518105
• MDR Report Key: 8800875
• Report Number: 2438477-2019-00037
• Device Sequence Number: 11519962
• Product Code: ITJ
• UDI-Device Identifier: 00822383585192
• UDI-Public: 822383585192
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2019
• Report Date (Section F): 07/17/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: 990X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/02/2019
• Device Age: 30 MO
• Event Location: Home
• Date Report to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 07/17/2019