BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE PEG TRAY

    MDR report key: 11789 · Received March 1, 1994

    Report

    Report Number
    MW1000908
    Event Type
    Injury
    Date Received
    March 1, 1994
    Date of Event
    January 26, 1994
    Report Date
    February 11, 1994
    Manufacturer
    U S ENDOSCOPY GROUP, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PEG WAS DONE ON PT ON 1/19/94 USING TRAY. THE PROCEDURE WENT WELL AND PT WAS STARTED ON G-TUBE FEEDINGS AFTER 24 HRS. A FEW DAYS LATER DRAINAGE WAS NOTED AROUND G-TUBE AND LATER INFECTION OF ABDOMINAL WALL WITH PURULENT DRAINAGE. G-TUBE WAS REMOVED ON 1/26/94 AND ON REMOVAL IT WAS NOTED THAT THE PIECE OF PLASTIC COVERING THE JOINT (TAPERED END AND MAIN PART OF G-TUBE) HAD COME OFF DURING INSERTION AND REMAINED IN THE ABDOMINAL WALL CAUSING AN INFECTION AND ABCESS. PT REQUIRED ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE PEG TRAY Implant KNT U S ENDOSCOPY GROUP, INC. 20 FR G/WIRE SILICONE PEG 131101

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention