BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BROOKS 130

    MDR report key: 16011231 · Received December 19, 2022

    Report

    Report Number
    3003124453-2022-00023
    Event Type
    Injury
    Date Received
    December 19, 2022
    Report Date
    December 19, 2022
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    PMA / PMN Number
    N/A#S-P#N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ATTACHMENT #1- INCIDENT INVESTIGATION REPORT. ATTACHMENT #2= WORK COMPLETION REPORT.

    Description of Event or Problem · 0

    THE CLIENT CONTACTED ACORN STAIRLIFTS TO SCHEDULE SERVICE FOR THE STAIRLIFT ON (B)(6) 2022. ACORN WAS ABLE TO MOVE FORWARD WITH INITIAL QUESITONS RELATED TO A PREVIOUS CALL FROM ACORN TO THE CLIENT WHERE THE CLIENT STATED THAT SHE HAD FALLEN OUT OF THE STAIRLIFT DUE TO DIZZINESS. THE RIDER WAS TRAVELLING DOWN THE STAIRS WHEN SHE GOT DIZZY, FELL OUT OF THE STAIRLIFT AND ROLLED DOWN THE STAIRS. THIS INCIDENT RESULTED IN BRUISING ON JER LEGS AND RIBS AS WELL AS A 10" LACERATION THAT REUIQRED STITCHES ON HER LEFT ARM. SHE COULD NOT RECALL WHEN THIS FALL OCCURRED. THE CONTRIBUTING FACTOR TO THE FALL AND INJURY WAS THAT THE RIDER WAS NOT USING THE SEAT BELT WHICH IS REQUIRED TO SAFELY RIDE THE STAIRLIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2842635 BROOKS 130 POWERED STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFTS, INC. RET 130

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention