BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RET 130 ACORN

    MDR report key: 15492148 · Received September 27, 2022

    Report

    Report Number
    3003124453-2022-00015
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    September 1, 2022
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    PMA / PMN Number
    N/A#S-P#N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2022, THE CUSTOMER CALLED ACORN STAIRLIFTS, INC. FOR SERVICE ON THE STAIRLIFT. IN THE COMMUNICATION, THE CUSTOMER REPORTED THAT THTE STAIRLIFT MOVES BEFORE SHE IS FULY SEATED ONTO THE LIFT; SHE REPORTED THAT IN ONE OCCURRENCE THAT THE STAIRLIFT STARTED TO MOVE DOWNWARD BEFORE SHE WAS SEATED. IN RESPONSE SHE LEPT OFF OF THE STAIRLIFT FEARING SHE WOULD FALL. IN THAT PROCESS. SHE STUMBLED AND FELL FORWARD ONTO THE UPSTAIRS FLOOR RESULTING IN A BROKEN LEFT ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304132 RET 130 ACORN POWERED STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFTS, INC. RET 130

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention| O