BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GILSDORF GASTROSTOMY CATHETER

    MDR report key: 282502 · Received June 15, 2000

    Report

    Report Number
    2429473-2000-00041
    Event Type
    Malfunction
    Date Received
    June 15, 2000
    Date of Event
    May 9, 2000
    Report Date
    June 14, 2000
    Manufacturer
    RUSCH, INC.
    Product Code
    KDH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE BALLOON OF THE GASTROSTOMY TUBE RUPTURED. THE CATHETER WAS REMOVED AND REPLACED. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GILSDORF GASTROSTOMY CATHETER GASTROSTOMY CATHETER KDH RUSCH, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR