BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCE GAP HALF LGT BED RAILS 9153601866

    MDR report key: 4348514 · Received December 19, 2014

    Report

    Report Number
    1531186-2014-06523
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    November 25, 2014
    Report Date
    November 25, 2014
    Manufacturer
    HL CORP. (SHENZHEN)
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE TBM STATES THAT THE ENDUSER ALLEGES HE WAS PULLING HIMSELF UP WITH THE RAIL AND THE BOLT SHEARED OFF AND THEY HEARD THE RAIL FALL. THE BED SERIAL NUMBER IS (B)(4) BUT THE CUSTOMER DOESN'T HAVE THE SAME RAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836375 REDUCE GAP HALF LGT BED RAILS 9153601866 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HL CORP. (SHENZHEN) 6630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other