BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 17371068 · Received July 21, 2023

    Report

    Report Number
    2438477-2023-00080
    Event Type
    Injury
    Date Received
    July 21, 2023
    Report Date
    August 2, 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
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A BED RAIL BY AN END USER'S AIDE, WHO STATED THAT SHE "FOUND [THE END USER] WITH HIS NECK AND ARM STUCK IN THE BED RAIL," AND THAT "THE SPRING-LOADED KNOB HAS FAILED AND THEY ARE NO LONGER ABLE TO ADJUST THE RAILS." THE AIDE DID NOT SPECIFY THE LOCATION WHERE THE END USER'S NECK AND ARM WERE STUCK. THE AIDE REPORTED THAT THE END USER SUSTAINED SOME BRUISING TO HIS KNEES, BUT DID NOT SPECIFY HOW THE BRUISING WAS RELATED TO THE INCIDENT. THE AIDE SPECIFIED THAT THE END USER DID NOT REQUIRE ANY MEDICAL TREATMENT. DRIVE MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER AND END USER IN ORDER TO RETRIEVE THE PRODUCT FOR INSPECTION BUT WAS UNABLE TO MAKE FURTHER CONTACT. DRIVE WILL CONTINUE TO MONITOR FOR ANY RELATED TRENDS.

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A BED RAIL BY AN END USER'S AIDE, WHO STATED THAT SHE "FOUND [THE END USER] WITH HIS NECK AND ARM STUCK IN THE BED RAIL," AND THAT "THE SPRING-LOADED KNOB HAS FAILED AND THEY ARE NO LONGER ABLE TO ADJUST THE RAILS." THE AIDE DID NOT SPECIFY THE LOCATION WHERE THE END USER'S NECK AND ARM WERE STUCK. THE AIDE REPORTED THAT THE END USER SUSTAINED SOME BRUISING TO HIS KNEES, BUT DID NOT SPECIFY HOW THE BRUISING WAS RELATED TO THE INCIDENT. THE AIDE SPECIFIED THAT THE END USER DID NOT REQUIRE ANY MEDICAL TREATMENT. DRIVE MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER AND END USER IN ORDER TO RETRIEVE THE PRODUCT FOR INSPECTION BUT WAS UNABLE TO MAKE FURTHER CONTACT. DRIVE WILL CONTINUE TO MONITOR FOR ANY RELATED TRENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106819 DRIVE BED RAILS FNL SHENYANG HENYI ENTERPRISE CO., LTD 15001ABV 00822383179490

    Patients

    Seq Age Sex Outcome Treatment
    1 Male