BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 16940773 · Received May 16, 2023

    Report

    Report Number
    2438477-2023-00034
    Event Type
    Injury
    Date Received
    May 16, 2023
    Report Date
    May 16, 2023
    Manufacturer
    SHENYANG HENYI ENTERPRISE CO., LTD
    Product Code
    FNL
    UDI-DI
    00822383111094
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT INVOLVING A BEDRAIL BY THE END USER'S SON, WHO REPORTED THAT HIS FATHER "HAS ALZHEIMER'S AND IS INJURING HIS ARMS BY PUTTING HIM THROUGH THE RAILS," AND THAT HE BELIEVES THE MANUFACTURER SHOULD "PROVIDE THE PADS TO KEEP THIS FROM HAPPENING." IT IS UNCLEAR WHAT PADS TO WHICH THE REPORTER REFERRED, AND THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THE SPECIFICS OR SEVERITY OF THE REPORTED INJURY. DRIVE IS CURRENTLY INVESTIGATING THE COMPLAINT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638207 DRIVE ELECTRIC BED FNL SHENYANG HENYI ENTERPRISE CO., LTD 15030 00822383111094

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other