BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRED BY DRIVE

    MDR report key: 15411636 · Received September 13, 2022

    Report

    Report Number
    3005328749-2022-00002
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    July 11, 2022
    Report Date
    September 13, 2022
    Manufacturer
    INOVO INC
    Product Code
    ILS
    UDI-DI
    00822383974613
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH TRANSFER SYSTEM BY AN END USER, WHO REPORTED THAT WHILE HE WAS SEATED ON THE SYSTEM AND BEING ROLLED ACROSS A WOOD FLOOR BY HIS CAREGIVER, "THE WHEELS ON THE TRANSFER BASE LOCKED UP AND [WOULD] NOT ROLL," WHICH CAUSED HIM TO BE RUN INTO A WALL. HE WAS TAKEN TO THE ER WHERE HIS LEFT LEG WAS X-RAYED, AND WAS RELEASED THE SAME DAY. THE DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608319 INSPIRED BY DRIVE BATH TRANSFER ILS INOVO INC BTUC-8131M-BB 00822383974613

    Patients

    Seq Age Sex Outcome Treatment
    1 Male