BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 17613375 · Received August 24, 2023

    Report

    Report Number
    2438477-2023-00110
    Event Type
    Injury
    Date Received
    August 24, 2023
    Report Date
    August 24, 2023
    Manufacturer
    SHENYANG HENYI ENTERPRISE CO., LTD
    Product Code
    FNL
    UDI-DI
    00822383179490
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A BED RAIL BY AN END USER'S HUSBAND, WHO STATED THAT SHE HAS "FALLEN OUT OF HER BED DUE TO THE RIGHT-SIDE RAIL NOT BEING UP." THE REPORTER STATED THAT KNOBS AND PINS OF THE RAIL WERE "JAMMED" OR BROKEN OFF. THE REPORTER DID NOT SPECIFY HOW THE RAIL CAME TO BE IN THAT CONDITION. THE END USER WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH 3 CRACKED RIBS. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO INSPECT THE PRODUCT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114703 DRIVE BED RAILS FNL SHENYANG HENYI ENTERPRISE CO., LTD 15001ABV 00822383179490

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization