BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAT 28 FR SUPER PEG/12 FR FRJ

    MDR report key: 92549 · Received May 19, 1997

    Report

    Report Number
    2110851-1997-00004
    Event Type
    Malfunction
    Date Received
    May 19, 1997
    Date of Event
    February 13, 1997
    Report Date
    May 9, 1997
    Manufacturer
    NOVARTIS NUTRITION
    Product Code
    KNT
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE INTERNAL BOLSTER OF A PEG/PEJ TUBE BECAME IMBEDDED IN THE PT'S MUCOSA. THE TUBE REPORTEDLY BECAME SEPARATED AT THE GASTRIC/FEEDING JUNCTION. NO PERFORATION OR SURGICAL INTERVENTION RESULTED FROM THIS INCIDENT. THE TUBE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT 28 FR SUPER PEG/12 FR FRJ PEG/PEC GASTROSTOMY TUBE KIT KNT NOVARTIS NUTRITION 085000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention