MAUDE Adverse Event Report: VIVE HEALTH VIVE HEALTH; Everglide Rollator (Model S)

Model Number	MOB1057
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that while using the rollator, the central hinge failed, causing him to fall to the ground and strike his head.He stated that he briefly lost consciousness for a few seconds.The patient reported that he was able to stand up and continue using the rollator afterward and did not seek medical attention.

• Brand Name: VIVE HEALTH
• Common Device Name: Everglide Rollator (Model S)
• Manufacturer (Section D): VIVE HEALTH; 8955 fontana del sol way; naples FL 34109
• MDR Report Key: 50141322
• Report Number: 50141322
• Device Sequence Number: 10722089
• Product Code: ITJ
• UDI-Device Identifier: 00810113573632
• UDI-Public: 00810113573632
• 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): 07/07/2026
• Report Date (Section F): 07/07/2026

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: MOB1057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2026
• Event Location: Other
• Date Report to Manufacturer: 07/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2026
• 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: Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 160 LB