MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT DRIVE; WALKER, MECHANICAL

Model Number	10289BL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	12/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an attorney, who alleged that the client was injured when her rollator failed during use resulting in wounds and a broken nose.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 21504893
• Report Number: 2438477-2025-00014
• Device Sequence Number: 19958455
• Product Code: ITJ
• UDI-Device Identifier: 00822383259345
• UDI-Public: (01)00822383259345
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2025
• Report Date (Section F): 03/03/2025

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: 10289BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2025
• Device Age: 5 YR
• Event Location: Home
• Date Report to Manufacturer: 03/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2025
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 57 KG
• Date Report Sent to FDA: 03/03/2025