BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIPLE-PORT GASTROSTOMY TUBE

    MDR report key: 217657 · Received April 5, 1999

    Report

    Report Number
    2429473-1999-00022
    Event Type
    Injury
    Date Received
    April 5, 1999
    Report Date
    April 5, 1999
    Manufacturer
    RUSCH INC.
    Product Code
    KDH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE GASTROSTOMY TUBE BECAME OCCLUDED; THE TUBE WAS SUBSEQUENTLY REPLACED WITH ANOTHER GASTROSTOMY TUBE, WHICH CAME OUT BY ITSELF IN 1/2 A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPLE-PORT GASTROSTOMY TUBE GASTROSTOMY CATHETER KDH RUSCH INC. NA 458279

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention