BEUDAMED
    FDA Adverse Event Injury Summary report: N

    180 T565 LH

    MDR report key: 11608866 · Received April 2, 2021

    Report

    Report Number
    3003124453-2021-00010
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    July 14, 2020
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE ACORN HAS NOT SPOKEN DIRECTLY TO THE USER. NEITHER OF THE DAUGHTERS ACORN SPOKE WITH LIVE WITH THEIR PARENTS AND THE USER'S WIFE WAS HOME BUT DID NOT WITNESS THE INCIDENT BECAUSE SHE WAS DOWN STAIRS. THE MOST LIKELY CAUSE IS THE USER IS NOT ABLE TO SIT IN THE CHAIR WITH HIS FEET BENT UNDER HIM ON THE FOOTREST EVERY TIME HE USES THE STAIRLIFT. THE USER WAS PRESENT AT THE INSTALLATION ON (B)(6) 2019 AND DID RECEIVE A DEMONSTRATION; HOWEVER, HIS PHYSICAL CONDITION HAS DEGRADED OVER THE PAST YEAR. IF THE USER IS NOT PHYSICALLY ABLE TO SIT ON THE CHAIR AS INSTRUCTED DURING THE DEMONSTRATION, OR HE FORGETS TO SIT IN THE CHAIR PROPERLY, HE PUT HIMSELF AT RISK OF SERIOUS INJURY OR DEATH. ACORN SENT THE USER A LETTER EXPLAIN THE IMPORTANCE OF SITTING IN THE CHAIR PROPERLY TO PREVENT SERIOUS INJURY OR DEATH. THE USER WAS IN BED DURING THE INVESTIGATION VISIT; HOWEVER, THE REGIONAL MANAGER WAS ABLE TO DEMO THE STAIRLIFT TO USER'S WIFE AND DAUGHTER.

    Description of Event or Problem · 1

    THE USER'S WIFE CALLED ACORN STAIRLIFTS, INC. (ACORN) ON (B)(6) 2020 WITH CONCERNS THAT THE STAIRLIFT STARTED BEEPING FOR NO REASON. ACORN REACHED OUT TO THE USER'S DAUGHTER AND WAS INFORMED THAT THE USER CUT HIS LEFT KNEE ON THE METAL HANDRAIL WHILE RIDING THE STAIRLIFT UPSTAIRS ON (B)(6) 2020. THE USER WAS TAKEN TO THE HOSPITAL AND RECEIVED 20 STAPLES IN HIS KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504968 180 T565 LH POWERED STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization CANE