BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIPLE-PORT GASTROSTOMY TUBE

    MDR report key: 303931 · Received November 2, 2000

    Report

    Report Number
    2429473-2000-00097
    Event Type
    Malfunction
    Date Received
    November 2, 2000
    Manufacturer
    RUSCH, INC.
    Product Code
    KDH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE CONNECTOR PORT OF THE GASTROSTOMY TUBES STRETCH AND, IN SOME CASES, BREAK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN