BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 10580005 · Received September 24, 2020

    Report

    Report Number
    3012316249-2020-00029
    Event Type
    Injury
    Date Received
    September 24, 2020
    Date of Event
    May 21, 2020
    Report Date
    September 24, 2020
    Manufacturer
    SICHUAN QILI ENTERPRISE INC.
    Product Code
    INM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER LEGAL DOCUMENTS: SPECIFIC DEFECT: BOTH FOOTRESTS HAVE A METAL BOLT STANDING VERTICALLY ON THE INSIDE OF BOTH FOOTRESTS. THERE IS NO PROTECTION FROM THIS SHARP METAL BOLT. NO PROTECTIVE COVER. BECAUSE OF THIS SAFETY DEFECT, WHEN ATTEMPTING TO MOVE MY LEG FROM THE FOOTREST TO THE FLOOR THE METAL BOLT SLICED MY OUTER LOWER LEG OPEN LEAVING A 6" SLICE AND 4 SQUARE INCH GASH, RESULTING IN AN EMERGENCY ROOM VISIT AND A HOSPITAL STAY FOLLOWED BY 9 WEEKS OF WOUND DOCTOR VISITS AND 9 WEEKS OF HOME NURSING CARE. NOT TO MENTION THE PHYSICAL PAIN AND EMOTIONAL TRAUMA THAT STILL CONTINUES, NOT KNOWING FOR HOW MUCH LONGER. MY LEG IS SCARRED AND DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048534 COMPASS HEALTH BRANDS TRANSPORT WHEELCHAIR 19X16 W/FOOTREST INM SICHUAN QILI ENTERPRISE INC. TCA1916BG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization