MAUDE Adverse Event Report: HANDICARE STAIRLIFTS B.V. HANDICARE 1100; POWERED STAIR CHAIR LIFT

Model Number	1100
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
User reported that lift travelled at speed and then a collision occurred.
Additional Manufacturer Narrative
As per investigation by distributor: contamination detected on device rail causing adverse operation.Unit removed from user property, returned to distributor for potential review and investigation.

• Brand Name: HANDICARE 1100
• Common Device Name: POWERED STAIR CHAIR LIFT
• Manufacturer (Section D): HANDICARE STAIRLIFTS B.V.; newtonstraat 35; p.o. box 39; heerhugowaard, noord-holland 1700 AA; NL 1700 AA
• MDR Report Key: 21769680
• Report Number: 3011268530-2025-00001
• Device Sequence Number: 8079620
• Product Code: PCD
• UDI-Device Identifier: 08719326254326
• UDI-Public: (01)08719326254326(11)230404
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2025
• Report Date (Section F): 03/28/2025

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: 1100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/07/2025
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 03/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic