MAUDE Adverse Event Report: CADENSE INC. CADENSE INC; ORIGINAL WOMEN'S R3

Model Number	SHORW
Medical Device Problem Code	Inadequate Instructions for Non-Healthcare Professional (2956)
Health Effect - Clinical Codes	Fall (1848); Multiple Fractures (4519)
Date of Event	09/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After investigation, it was discovered that the user did not understand the technology in the shoes.She did not read the informational placard or watch the videos emailed to her after purchase.She acknowledged receiving both but not paying attention to them.Multiple meetings of cadense management took place to discuss options to better educate customers.The corrective action is still to be determined.
Event or Problem Description
Customer was wearing cadense original shoes while working as a cleaning person at panera bread.The ground was wet concrete, sloping downward slightly.She slipped and fell to the ground, which led to a broken ankle.She called an ambulance to help her off the ground and ultimately got surgery on her ankle.

• Brand Name: CADENSE INC
• Common Device Name: ORIGINAL WOMEN'S R3
• Manufacturer (Section D): CADENSE INC.; 935 west campus ln; goleta CA 93117
• Manufacturer Contact: tyler susko ; 935 west campus ln; goleta, CA 93117 ; 4844378553
• MDR Report Key: 23387793
• Report Number: 3039167356-2025-00001
• Device Sequence Number: 15714994
• Product Code: KNP
• UDI-Device Identifier: 00810195430564
• UDI-Public: 00810195430564
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2025

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: SHORW
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American