MAUDE Adverse Event Report: EZ WAY INC EZ STAND

Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Cna had hooked up resident to stand using large harness.Left her hooked up while using toilet.When done, resident called for assistance.She was raised to almost standing position.Did pericare and resident was standing for approximately 1 minute before pulling up pants.Cna pulled stand away from the toilet and the left side harness loop came off.Resident fell backward and hit head.
Additional Manufacturer Narrative
Patient was putting her arm all the way over the bar of the stand, making the loop of the harness slide up over the safety tab.

• Brand Name: EZ STAND
• Common Device Name: 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: 24032058
• Report Number: 2183887-2026-00003
• Device Sequence Number: 21100970
• Product Code: FSA
• UDI-Device Identifier: 00848914007971
• UDI-Public: (01)00848914007971
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 01/10/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG