BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACORN

    MDR report key: 15866922 · Received November 26, 2022

    Report

    Report Number
    3003124453-2022-00021
    Event Type
    Injury
    Date Received
    November 26, 2022
    Date of Event
    July 18, 2022
    Report Date
    November 26, 2022
    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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ACORN MANAGEMENT AND TEAM REVIEWED THE SURVEY AND INSTALLATION DOCUMENTION/RECORDS. THE SURVEY SPECS WERE FOUND TO ALLOW SIGNIFICANT CLEARANCE FOR THE CLIENT TO RIDE THE STAIRLIFT UNOBSTRUCTED. A DEMO WAS GIVEN TO THE CLIENTS, THE HUSBAND WHO IS SIGNFICANTLY TALLER THAN HIS SPOUSE COMPLETED THE RIDER TRAINING. THERE WAS NO ISSUE IN THE DEMO WITH THE RIDER HAVING CONTACT WITH ANYTHING DURING THE DEMO. BASED ON THE LACK OF INFORMATION DUE TO ACORN NOT ABLE TO COMPLETE THE INVESTIGATION. IT IS UNCLEAR HOW THE RIDER SUSTAINED THE LACERATION.

    Description of Event or Problem · 0

    ON (B)(6) 2022, ACORN STAIRLIFTS, INC. (ACORN) RECEIVED A LETTER FROM A THIRD PARTY. IT CLAIMED THE CLIENT WAS INJURED WHILE USING THE STAIRLIFT. THE LETTER STARTED THAT ON OR ABOUT (B)(6) 2022, THE RIDER WAS USING THE STAIRLIFT TO GO UP THE STAIRS WHEN HER RIGHT KNEE CAME INTO CONTACT WITH THE STAIRCASE HANDRAIL AND WAS CAUGHT. THIS RESULTED IN A LACERATION THAT REQUIRED 15 STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113343 ACORN POWERED STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFTS, INC. 130 T700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention