BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 973666 · Received December 27, 2007

    Report

    Report Number
    MW5004844
    Event Type
    Injury
    Date Received
    December 27, 2007
    Date of Event
    December 16, 2007
    Report Date
    December 19, 2007
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PEG TUBE CLOGGED/OBSTRUCTED, UNABLE TO CLEAR AND THUS REASON FOR ADMISSION. GI CONSULT ORDERED. PT STARTED ON D-5 NORMAL SALINE. PT ALSO PLACED PROPHYLACTICALLY ON LOVENOX AND IV NEXIUM. TRACHEOSTOMY CHANGED DURING HOSPITALIZATION. BOTH NOT RELATED TO CHEMOTHERAPY 2007 SAE ENDED. PT D/C FROM HOSPITAL WITHOUT SEQUELAE AND RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA PEG TUBE KNT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization DEXAMETHASONE 4MG TAB| PO BID X 3D BEGINNING ONEDAY PRIOR TO CHEMOTHERAPY| FOLIC ACID 0.8MG TAB SQD