BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE

    MDR report key: 6998128 · Received November 2, 2017

    Report

    Report Number
    2438477-2017-00033
    Event Type
    Death
    Date Received
    November 2, 2017
    Date of Event
    March 7, 2017
    Report Date
    March 7, 2017
    Manufacturer
    FORT METAL PLASTIC CO., LTD.
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE IN QUESTION. WE RECEIVED AN EMAIL NOTIFICATION OF THE DEATH OF A PATIENT FROM A NURSING HOME. THERE SEEMS TO BE INCONSISTENCY IN THE REPORT FROM THE FACILITY. ONE PERSON SAID THAT PATIENT SLID DOWN OFF THE SIDE OF THE BED AND HER HEAD GOT STUCK AT THE END OF THE RAIL, WHILE ANOTHER SUGGESTED THAT THE PATIENT BECAME STUCK IN BETWEEN THE BARS OF THE RAIL. AT THIS TIME, WE DO NOT KNOW THE TYPE OF BED TO WHICH THE RAIL WAS PAIRED, AND HOW IT WAS INSTALLED PRIOR TO THE INCIDENT. THIS REPORT IS BASED ON THE INFORMATION THAT WAS PROVIDED BY THE CUSTOMER AND ATTORNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775354 DRIVE BED RAIL FNJ FORT METAL PLASTIC CO., LTD. 16500BV

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death