BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 18870238 · Received March 8, 2024

    Report

    Report Number
    2438477-2024-00012
    Event Type
    Injury
    Date Received
    March 8, 2024
    Report Date
    March 8, 2024
    Manufacturer
    JIANGYIN HUASHI MEDICAL
    Product Code
    FNJ
    UDI-DI
    00822383143361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BED RAIL BY A PATIENT, WHO REPORTED THAT AS HE USED THE RAIL TO ASSIST WITH STANDING UP, THE BAR BENT AND HE FELL TO THE FLOOR, BREAKING HIS HIP AND SUSTAINING OTHER BRUISES. DRIVE DEVILBISS HEALTHCARE IS IN THE PROCESS OF FACILITATING THE RETURN OF THE PRODUCT FOR INSPECTION AND WILL UPDATE THIS REPORT SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168632 DRIVE BED, MANUAL FNJ JIANGYIN HUASHI MEDICAL 15021BV 00822383143361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention