MAUDE Adverse Event Report: VIVE HEALTH VIVE HEALTH; Core Rollator

Model Number	MOB1106
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	07/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported an injury involving the use of a rollator walker.According to the initial report, the customer was being pushed by another individual while seated on the device in a parking lot area.When the walker encountered an uneven surface or bump transitioning from the parking lot to the sidewalk, the device reportedly collapsed, causing the customer to fall backward and strike the back of their head on the asphalt.The customer also reported additional minor injuries, including scrapes, and indicated that the assisting individual sustained a leg injury during the incident.The customer sought medical evaluation in the emergency room, where imaging (x-rays and ct scan) was performed to rule out serious complications.It is important to note that communication with the customer has ceased, and no further details or clarification have been obtained since the initial report.Additionally, the product's instruction manual clearly states: "do not push a person seated on the rollator.The rollator is a walking aid only and not to be used as a transportation device." based on the information provided, the device appears to have been used in a manner inconsistent with its intended use and labeled instructions.

• Brand Name: VIVE HEALTH
• Common Device Name: Core Rollator
• Manufacturer (Section D): VIVE HEALTH; 8955 fontana del sol wa; naples FL 34109
• MDR Report Key: 50234782
• Report Number: 50234782
• Device Sequence Number: 13347696
• Product Code: ITJ
• UDI-Device Identifier: 00810113577173
• UDI-Public: 00810113577173
• 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: User Facility
• Type of Report: Initial
• Report Date (Section B): 08/04/2026
• Report Date (Section F): 08/04/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MOB1106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/04/2026
• Event Location: Other
• Date Report to Manufacturer: 08/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2026
• 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: Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 170 LB
• Patient Race: White