BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDICARE 1100

    MDR report key: 21769680 · Received April 3, 2025

    Report

    Report Number
    3011268530-2025-00001
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 2, 2025
    Manufacturer
    HANDICARE STAIRLIFTS B.V.
    Product Code
    PCD
    UDI-DI
    08719326254326
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    USER REPORTED THAT LIFT TRAVELLED AT SPEED AND THEN A COLLISION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744427 HANDICARE 1100 POWERED STAIR CHAIR LIFT PCD HANDICARE STAIRLIFTS B.V. 1100 08719326254326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization