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

Model Number	10289RD
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Hip Fracture (2349)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by the end user's daughter, who reported that the "rivet holding the handle for the left brake fell out" and caused the end user to fall and break her hip.Drive devilbiss healthcare is in the process of facilitating the return of the product for evaluation and will update this report should any additional information become available.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD.; 1318 west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 18890445
• Report Number: 2438477-2024-00013
• Device Sequence Number: 15351236
• Product Code: ITJ
• UDI-Device Identifier: 00822383259338
• UDI-Public: 00822383259338
• 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): 03/12/2024
• Report Date (Section F): 03/12/2024

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: 10289RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/13/2024
• Date Report to Manufacturer: 03/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2024
• 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
• Date Report Sent to FDA: 03/12/2024