BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDICARE

    MDR report key: 22680838 · Received July 31, 2025

    Report

    Report Number
    3013423626-2025-00005
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    May 10, 2025
    Report Date
    July 22, 2025
    Manufacturer
    HANDICARE STAIRLIFTS B.V.
    Product Code
    PCD
    UDI-DI
    08719326254326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    CLIENT FELL DOWN STAIRS WHEN STAIRLIFT FAILED DUE TO INSTALLATION ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160958 HANDICARE POWERED STAIRWAY CHAIR LIFT PCD HANDICARE STAIRLIFTS B.V. 1100 08719326254326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization