MAUDE Adverse Event Report: SAVARIA NEDERLAND B.V. SAVARIA NEDERLAND B.V.; STAIRLIFT

Model Number	1100
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A blind user stepped out of the stairlift prematurely, causing her to fall.She thought she was at the bottom.
Additional Manufacturer Narrative
A blind user stepped out of the stairlift prematurely, causing her to fall.She thought she was at the bottom.We are reviewing the event for potential product improvement.

• Brand Name: SAVARIA NEDERLAND B.V.
• Common Device Name: STAIRLIFT
• Manufacturer (Section D): SAVARIA NEDERLAND B.V.; savaria nederland b.v.; newtonstraat 35; heerhugowaard
• Manufacturer (Section G): SAVARIA NEDERLAND B.V.; savaria nederland b.v.; newtonstraat 35; heerhugowaard, ; NL
• Manufacturer Contact: peter laan ; savaria nederland b.v.; newtonstraat 35; heerhugowaard, 1704S-B ; NL 1704SB
• MDR Report Key: 25519497
• Report Number: 3013423626-2026-00002
• Device Sequence Number: 13265446
• Product Code: PCD
• UDI-Device Identifier: 08719326254326
• UDI-Public: 8719326254326
• 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: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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: Lay User/Patient
• Device Model Number: 1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female