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

Model Number	790
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	01/30/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 2438477-2017-00090
• Device Sequence Number: 11526442
• Product Code: ITJ
• UDI-Device Identifier: 00822383183589
• UDI-Public: 822383183589
• Combination Product (Y/N): N
• 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): 05/11/2020
• Report Date (Section F): 05/11/2020

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: 790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/11/2020
• Device Age: 4 YR
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2020
• 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: 05/11/2020