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

Model Number	790
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving a knee walker by the end user, who stated that the seat post broke during use causing her to fall.The end user cut the back of her left thigh on the broken seat post and subsequently received seven stitches.As part of its complaint review and evaluation process, drive medical will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): HL CORP. (SHENZHEN); the 3rd industrial park; bitou village song gang town; baoan district shenzhen, guangdong 51810 5; CH 518105
• MDR Report Key: 25443268
• Report Number: 2438477-2026-00032
• Device Sequence Number: 5726195
• Product Code: ITJ
• UDI-Device Identifier: 00822383183589
• UDI-Public: (01)00822383183589
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/09/2026
• Report Date (Section F): 06/09/2026

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: 05/13/2026
• Event Location: Home
• Date Report to Manufacturer: 06/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2026
• 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; Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Date Report Sent to FDA: 06/09/2026