BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACORN

    MDR report key: 16484830 · Received March 6, 2023

    Report

    Report Number
    3003124453-2023-00011
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    January 18, 2023
    Report Date
    March 5, 2023
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    PMA / PMN Number
    NA#S-P#NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FULL INVESTIGATION REPORT IS ON FILE WITH ACORN STAIRLIFTS, INC.

    Description of Event or Problem · 0

    ACORN STAIRLIFTS, INC RECEIVED A CALL FROM THE CLIENT ON 2.07.2023 FOR SERVICE OF HIS STAIRLIFT. DURING THE CONVERSATION, THE CLIENT COMMUNICATED THAT ON (B)(6) 2023, HE HAD TAKEN A FALL TRYING TO GET INTO THE STAIRLIFT. THE STAIRLIFT WAS AT THE TOP LANDING, THE CLIENT ATTEMPTED TO GET INTO THE STAIRLIFT, HISLEFT MISSED THE FOOTREST ON THE STAIRLIFT AND HE STEPPED OFF THE TOP STEP. HE FELL 22 STAIRS RESULTING IN C3 FRACTURE. THE CLIENT ALSO COMMUNICATED THAT HE HAD TAKEN MULTIPLE FALLS OVER A SHORT TIME; 4 FALLS IN TWO MONTHS AS HE WAS ALSO IN THE MIDST OF BATTLING COVID. HE STATED HE WAS IN A DAZE AND HAVING MEMORY AND BALANCE CHALLENGES DURING THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611917 ACORN POWERED STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFTS, INC. 180 T565 RH USA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other| R| H