MAUDE Adverse Event Report: EZ WAY INC EZ LIFT

Model Number	L500PS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Head Injury (1879); Vertebral Fracture (4520)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Cnas were transferring the resident from an electric wheelchair to a recliner.They hooked the resident up, lifted her, and before they reached the recliner(2 or 3 feet away from wheelchair), the back, right, shoulder strap came off the hanger bar.The resident fell backwards, and they said her feet went over her head and she landed on her stomach.
Additional Manufacturer Narrative
Assistant admin said they had tried to recreate the incident with different positioning of the sling strap on the hanger bars.They had 5 staff members involved, and they could not recreate the incident.Wonders if the strap was stuck on the top part of the sling hanger.

• Brand Name: EZ LIFT
• Common Device Name: LIFT
• 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: 24032047
• Report Number: 2183887-2026-00001
• Device Sequence Number: 10551699
• Product Code: FSA
• UDI-Device Identifier: 00848914000057
• UDI-Public: (01)00848914000057
• 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: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• 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
• Device Model Number: L500PS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2012
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 168 KG