MAUDE Adverse Event Report: EZ WAY INC EZ WAY SMART STAND; SIT TO STAND

Model Number	S400PN-03
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Resident was using commode.The aide got the resident hooked up to the stand and she checked his feet and hands before lifting.The stand stopped on its own about halfway up.The cna did peri care for the resident.The stand would not go all the way up, so the cna got a wheelchair to lower the resident onto.Before she could do so, the resdient said he was going down.He wasn't able to hang onto the handle grips.The cna helped the resident to the floor.The resident said he heard a pop or snap sound.The resident refused to go to the er that day.The next day, there were visible signs of injuries on the resident.He went to er the following morning and was in 10 out of 10 for pain.He had surgery done on his leg for a broken femur.
Additional Manufacturer Narrative
Client had a hip replacement that was infected, hardware was removed, no hip at time of incident.

• Brand Name: EZ WAY SMART STAND
• Common Device Name: SIT TO STAND
• Manufacturer (Section D): EZ WAY INC; 710 east main street; clarinda IA 51632
• Manufacturer (Section G): EZ WAY INC; 710 east main street; clarinda IA 51632
• Manufacturer Contact: amy scott ; 710 east main street; clarinda, IA 51632 ; 7125421814
• MDR Report Key: 24675722
• Report Number: 2183887-2026-00004
• Device Sequence Number: 13315766
• Product Code: FSA
• UDI-Device Identifier: 00848914000149
• UDI-Public: (01)00848914000149
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: Health Professional
• Device Model Number: S400PN-03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 112 KG