BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSS

    MDR report key: 230961 · Received June 11, 1999

    Report

    Report Number
    MW1016691
    Event Type
    Death
    Date Received
    June 11, 1999
    Date of Event
    March 15, 1999
    Report Date
    May 21, 1999
    Manufacturer
    MOSS TUBES, INC.
    Product Code
    KNT
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BALLOON PORT/LUMEN LEAKED WATER DURING THE NIGHT FOLLOWING CATHETER INSERTION, THE BALLOON DEFLATED. FEEDS/GASTRIC CONTENTS LEAKED AROUND THE CATHETER INTO THE SUBCUTANEOUS AND SUBFASCIAL PLAINS. THE CATHETER WAS RETURNED (NURSE RETURNING) INTO STOMACH AND STOMACH TAKEN UP TO THE PERITONEUM. PT REQUIRED OPERATIVE DEBRIDEMENT OF ABDOMINAL WALL, DEVELOPED ORGAN FAILURE ("SIRS") AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSS Implant GASTROSTOMY TUBE 18 F. KNT MOSS TUBES, INC. * 1100B

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death