MAUDE Adverse Event Report: VIVE HEALTH VIVE HEALTH LLC; 3 WHEEL WALKER ROLLATOR MOB1026

Model Number	MOB1026
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer experienced a fall and fractured her fibula.She required surgery followed by physical therapy.The incident occurred as she was turning the corner from her kitchen to her bathroom, where she lost her balance.

• Brand Name: VIVE HEALTH LLC
• Common Device Name: 3 WHEEL WALKER ROLLATOR MOB1026
• Manufacturer (Section D): VIVE HEALTH; 8955 fontana del sol way; naples FL 34109
• MDR Report Key: 23348845
• Report Number: 3011191255-2025-00013
• Device Sequence Number: 15820204
• Product Code: ITJ
• UDI-Device Identifier: 00818323027952
• UDI-Public: 00818323027952
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2025
• Report Date (Section F): 10/01/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MOB1026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2025
• Event Location: Home
• Date Report to Manufacturer: 10/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2025
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 71 KG