MAUDE Adverse Event Report: APEX HEALTHCARE MFG. INC HOYER ADVANCE LIFT; PATIENT LIFT

Model Number	HOY-ADVANCE-E
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report or other information submitted by joerns healthcare under 21 cfr part 803, and release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare, its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.
Event or Problem Description
It was reported to the manufacturer, by the end user, per the end user, that reporting the spreader bar transport basket appears to be hanging on the bolt or pin too loose, and also will not hold the spreader bar when placed in the basket.- also saying the elastic leg restraining needs to be replaced (states the plastic knob is broken) contributing to an injury.- fyi - found chg repl (b)(4) for a battery, no defect upon return and inspection - states injury to fingernail on left middle finger saw blood under fingernail (incident rpt created).- states this was caused from the plastic knob on the elastic leg restraint; but then says it was caused from the leg of the lift hitting her finger when the lift was being stored in the folded position.Complaint #(b)(4).Was entered into our system.

• Brand Name: HOYER ADVANCE LIFT
• Common Device Name: PATIENT LIFT
• Manufacturer (Section D): APEX HEALTHCARE MFG. INC; no. 6 industrial 2nd road; tou chiao industrial park; min hsuing, chai yi hsi ; TW
• Manufacturer (Section G): APEX HEALTHCARE MFG. INC; no. 6 industrial 2nd road; tou chiao industrial park; min hsuing, chai yi hsi ; TW
• Manufacturer Contact: mackenzie bsy ; avenida pedro hinojosa no. 26; ciudad industrial; matamoras, tamaulipas 87499 ; MX 87499
• MDR Report Key: 22627018
• Report Number: 3009402404-2025-00028
• Device Sequence Number: 9251658
• Product Code: FSA
• UDI-Device Identifier: 00810055880041
• UDI-Public: 00810055880041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2025

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: HOY-ADVANCE-E
• Device Catalogue Number: HOY-ADVANCE-E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/28/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Unknown