BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 494735 · Received November 3, 2003

    Report

    Report Number
    MW1030050
    Event Type
    Injury
    Date Received
    November 3, 2003
    Date of Event
    October 30, 2003
    Report Date
    November 3, 2003
    Manufacturer
    *
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH C/O DISCOMFORT AT G-TUBE SITE AND "LEAKING" FROM TUBE. THE PT WAS RELEASED AFTER G-TUBE REPLACED WITH FOLEY AND PT WITH REFERRAL TO SURGERY CLINIC FOR REVISION OF G-TUBE. THE PT PRESENTED IN ENT/ONCOLOGY CLINIC THE NEXT DAY WITH CONTINUED C/O OF INCREASED DISCOMFORT AT G-TUBE SITE AND EXTERNAL EXCORIATION NOTED AT SITE AS WELL AS SIGNIFICANT DRAINAGE/LEAKAGE FROM G-TUBE NOTED. THE PT WAS ADMITTED TO THE HOSP TO EVALUATE THE G-TUBE AND SECONDARILY TO HYDRATE AND NUTRITIONALLY SUPPORT THE PT. THE PT WAS DETERMINED TO HAVE INFECTION AT THE G-TUBE SITE AND IS TREATED WITH IV ANTIBIOTICS. THE PT CONTINUES HOSPITALIZED AT THE TIME OF THIS REPORT IN STABLE AND IMPROVING CONDITION. THE PT HAD POOR NUTRITIONAL STATUS AND WEIGHT LOSS AT TIME OF ADMISSION SECONDARY TO RESIDUAL DYSPHAGIA RELATED TO RADIATION TREATMENT AND THE PT USED THE G-TUBE INFREQUENTLY PER SELF-REPORT. THE PT APPEARED TO HAVE ADEQUATE IMMUNE RESPONSE AT TIME OF ADMISSION-LAB VALUES AT ADMIT. THE PT HAS NOT BEEN CONSISTENT WITH ADHERENCE TO MEDICAL ADVICE AT TIMES AND HAS NOT DEMONSTRATED STANDARD CARE/PRECAUTIONS WITH THE G-TUBE WHICH MAY BE CONTRIBUTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * G-TUBE KNT * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization