BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCVE REPL, 5:4 HD CPLR, AC

    MDR report key: 6947624 · Received October 13, 2017

    Report

    Report Number
    3003604053-2017-00129
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    December 19, 2014
    Report Date
    October 13, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FEI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEIVCE COULD NOT BE SEEN THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729594 SCVE REPL, 5:4 HD CPLR, AC INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE FEI SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1