BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 11323258 · Received February 12, 2021

    Report

    Report Number
    2438477-2021-00002
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    December 1, 2020
    Report Date
    February 11, 2021
    Manufacturer
    SHENYANG HENYI ENTERPRISE CO., LTD
    Product Code
    FNL
    UDI-DI
    00822383179490
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED RAIL. WE HAVE NOT EVALUATED THE DEVICE AS THE SERVICE PROVIDER IS HOLDING IT AT THEIR FACILITY. WE WILL FILE A FOLLOW-UP REPORT ONCE WE ARE ABLE TO EVALUATE THE DEVICE AND/OR RECEIVE ADDITIONAL INFORMATION. END-USER REPORTED HE HAD TO GO TO THE HOSPITAL DUE TO A CUT AND INFECTION IN HIS RIGHT LEG. HE WAS NOT SURE HOW HE GOT THE CUT ON HIS LEG. AFTER BEING DISCHARGED FROM THE HOSPITAL HE FOUND A "SHARP SPOT" ON THE SIDE RAILS THAT CUT HIS HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219926 DRIVE BED FNL SHENYANG HENYI ENTERPRISE CO., LTD 15001ABV 00822383179490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization