BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 6580216 · Received May 19, 2017

    Report

    Report Number
    2438477-2017-00049
    Event Type
    Injury
    Date Received
    May 19, 2017
    Report Date
    April 21, 2017
    Manufacturer
    ZHONGSHAN REXON REHABILITATION EQUIPMENT COMPANY
    Product Code
    IKX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) RECEIVED NOTIFICATION OF AN INCIDENT INVOLVING A COMMODE CHAIR THAT (B)(4) IMPORTS AND DISTRIBUTES. THE ENDUSER WAS ATTEMPTING TO REMOVE THE COMMODE BUCKET AND ALLEGEDLY, THE TOILET SEAT BECAME UNHINGED CAUSING HER TO FALL. SHE WAS ALLEGEDLY TAKEN TO THE EMERGENCY ROOM AT (B)(6) HOSPITAL AND HAD X-RAYS TAKEN. SHE SUFFERED A HAIRLINE FRACTURE IN HER RIGHT ELBOW. THE ENDUSER REQUESTED A REPLACEMENT COMMODE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360309 DRIVE MEDICAL COMMODE CHAIR IKX ZHONGSHAN REXON REHABILITATION EQUIPMENT COMPANY 11117N-1

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization