BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMOBIL CHAIRMAN 2K

    MDR report key: 535348 · Received February 20, 2004

    Report

    Report Number
    1221084-2004-00003
    Event Type
    Other
    Date Received
    February 20, 2004
    Date of Event
    February 12, 2004
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THE USER WAS SITTING IN THEIR PERMOBIL POWERED WHEELCHAIR WHEN THE BACKREST SUDDENLY GAVE WAY. THE USER SLID OUT FROM THE SEAT AND SUSTAINED A LACERATION ON THEIR BUTTOCKS. INJURY NOT SERIOUS, BUT USER IS SLOW TO HEAL, REQUIRING MEDICAL TREATMENT AND FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMOBIL CHAIRMAN 2K POWERED WHEELCHAIR ITI PERMOBIL AB 1280 4100181

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention