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

Model Number	RTL12505
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a steerable knee walker by an end users' mother, who reported that the knee pad post broke and her son "fell to the ground and got hurt." drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: STEERABLE KNEE WALKER
• 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: 16723593
• Report Number: 2438477-2023-00023
• Device Sequence Number: 7225817
• Product Code: ITJ
• UDI-Device Identifier: 00822383247151
• UDI-Public: 00822383247151
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2023
• Report Date (Section F): 04/12/2023

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: RTL12505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2023
• Device Age: 7 YR
• Date Report to Manufacturer: 04/19/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 04/12/2023