MAUDE Adverse Event Report: VIVE HEALTH VIVE HEALTH LLC; KNEE WALKER

Model Number	MOB1007
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer recently had foot surgery, and while using the item, she fell and hit the foot that underwent surgery.She reports that this happened because the item is too unstable and dangerous.

• Brand Name: VIVE HEALTH LLC
• Common Device Name: KNEE WALKER
• Manufacturer (Section D): VIVE HEALTH; 8955 fontana del sol way; naples FL 34109
• MDR Report Key: 21241187
• Report Number: 3011191255-2025-10004
• Device Sequence Number: 8551586
• Product Code: ITJ
• UDI-Device Identifier: 00818323024937
• UDI-Public: 00818323024937
• 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): 01/23/2025
• Report Date (Section F): 01/23/2025

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
• Device Model Number: MOB1007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 12/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2025
• 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 Sex: Female
• Date Report Sent to FDA: 01/23/2025