BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL, INC.

    MDR report key: 53684 · Received November 27, 1996

    Report

    Report Number
    53684
    Event Type
    Malfunction
    Date Received
    November 27, 1996
    Date of Event
    September 16, 1996
    Report Date
    October 21, 1996
    Manufacturer
    DAVOL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PORT WAS REMOVED FROM PT DUE TO TWO CRACKS IN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL, INC. Implant GROSHONG CATHETER DQO DAVOL, INC. 602851 36KB1561

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO