BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GILSDORF GASTROSTOMY CATHETER

    MDR report key: 224391 · Received May 19, 1999

    Report

    Report Number
    2429473-1999-00044
    Event Type
    Injury
    Date Received
    May 19, 1999
    Date of Event
    May 17, 1999
    Report Date
    May 18, 1999
    Manufacturer
    RUSCH, INC.
    Product Code
    KDH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE BALLOON INFLATION PORT PLUG POPPED OUT. THE DEVICE HAD BEEN IN PLACE FOR APPROX 1 MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GILSDORF GASTROSTOMY CATHETER GASTROSTOMY CATHETER KDH RUSCH, INC. NA 726030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other