MAUDE Adverse Event Report: VIVE HEALTH VIVE HEALTH; All Terrain Knee Walker

Model Number	MOB1019
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that while using the mobility scooter, the seat rotated unexpectedly twice, causing her to fall in her garage.During the fall, she struck her ankle against brick steps.The customer reported sustaining an ankle fracture and a severe ankle sprain.She sought medical attention and reported that treatment included remaining non-weight-bearing for two weeks and the use of an ankle brace and walking boot for an estimated 4 to 12 weeks.The customer stated that, due to the pain following the incident, she immediately packaged and returned the product and did not take photographs.At the time of this report, the device has not been received for evaluation.Based on the information available, the customer's description of the event is not sufficiently clear to determine the cause of the reported incident.The customer reported that the seat rotated out of position twice; however, it could not be determined whether the seat was properly locked in place prior to use.
Additional Manufacturer Narrative
The device is not available for evaluation.Based on the customer's description, the reported issue involved the swivel seat rotating out of position.The seat is designed with a user-tightened locking bolt intended to secure the seat and prevent rotation during use.Without the returned device, the condition of the seat and its use at the time of the event could not be verified.

• Brand Name: VIVE HEALTH
• Common Device Name: All Terrain Knee Walker
• Manufacturer (Section D): VIVE HEALTH; 8955 fontana del sol way; naples FL 34109
• MDR Report Key: 50234781
• Report Number: 50234781
• Device Sequence Number: 10341872
• Product Code: ITJ
• UDI-Device Identifier: 00818323022896
• UDI-Public: 00818323022896
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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
• Device Model Number: MOB1019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/03/2026
• Event Location: Home
• 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; Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 302 LB