MAUDE Adverse Event Report: HL CORP. DRIVE; WALKER, MECHANICAL

Model Number	790
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a knee walker by an attorney letter alleging that while in use by the end user, the "handlebars dropped and/or collapsed causing her to lose balance fall and sustain serious injuries and damages," which are alleged to include a right achilles tendon rupture and "chronic" regional pain syndrome.Drive is attempting to investigate the incident through cooperation with the end user's attorney.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): HL CORP.; the 3rd industrial park; bitou village, song gang town; baoan district, shenzhen guangdong 51810 5; CH 518105
• MDR Report Key: 23522602
• Report Number: 2438477-2025-00062
• Device Sequence Number: 15921975
• Product Code: ITJ
• UDI-Device Identifier: 00822383183589
• UDI-Public: (01)00822383183589
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2025
• Report Date (Section F): 11/11/2025

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?: Yes
• 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: 10/15/2025
• Event Location: Home
• Date Report to Manufacturer: 11/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• 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: Other; Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 11/11/2025