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

Model Number	1100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Laceration(s) (1946)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Client fell down stairs when stairlift failed due to installation error.
Additional Manufacturer Narrative
Initial information reported did not indicate this was a reportable event, but upon site visit with detailed inspection on (b)(6) 2025, we determined that it was reportable.

• Brand Name: HANDICARE
• Common Device Name: POWERED STAIRWAY CHAIR LIFT
• Manufacturer (Section D): HANDICARE STAIRLIFTS B.V.; newtonstraat 35; po box 39; heerhugowaard, noord holland 1700 AA; NL 1700 AA
• Manufacturer (Section G): HANDICARE; newtonstraat 35; po box 39; heerhugogaard, noord holland 1700 AA; NL 1700 AA
• Manufacturer Contact: peter laan ; newtonstraat 35; po box 39; heerhugowaard, noord holland 1700 -AA ; NL 1700 AA
• MDR Report Key: 22680838
• Report Number: 3013423626-2025-00005
• Device Sequence Number: 8937157
• Product Code: PCD
• UDI-Device Identifier: 08719326254326
• UDI-Public: 08719326254326
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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
• Device Model Number: 1100
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/31/2025
• 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: Hospitalization
• Patient Sex: Male
• Patient Weight: 100 KG