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

Model Number 790

Device Problem Solder Joint Fracture (2324)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 01/30/2017

Event Type  Injury  

Event Description

Drive devilbiss is the initial importer of the device which is a knee walker.This report is being tendered in an overabundance of caution in response to an mdr regression analysis.The device's seat post failed which caused the customer to fall.She hit her head and received a minor concussion.Since this incident a design change under pc#297 (2016/2017) has addressed the seat post issue.The serial number provided shows that the unit was manufactured in 2013, prior to the changes.

• Brand Name: DRIVE
• Type of Device: KNEE WALKER
• Manufacturer (Section D): HL CORP (SHENZHEN); 3rd industrial park; bitou village song gang town; baon district, shenzhen guangdong, 51810 5; CH 518105
• MDR Report Key: 10043976
• MDR Text Key: 191591504
• Report Number: 2438477-2017-00090
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383183589
• UDI-Public: 822383183589
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2020
• Distributor Facility Aware Date: 05/11/2020
• Device Age: 4 YR
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention