BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT TUBE

    MDR report key: 2181308 · Received July 21, 2011

    Report

    Report Number
    1527460-2011-00046
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    May 28, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) TUBE REPLACEMENT. THE DEVICE REPORTED, LIST NUMBER 56548, IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 51364, THAT IS MARKETED DOMESTICALLY. IF ADDITIONAL INFORMATION/CLARIFICATION IS OBTAINED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.

    Description of Event or Problem · 1

    A FEMALE PT (B)(6) RECEIVED A PEG TUBE PLACEMENT 1.5 YEARS AGO. ON (B)(6) 2011, A FLEXIFLO 20 FRENCH GASTROSTOMY TUBE WAS PLACED AS REPLACEMENT OF PREVIOUS GASTROSTOMY TUBE. THE NEXT DAY, THE PHYSICIAN SAW AN OUTPUT OF GASTRIC CONTENTS AND FOOD THROUGH THE GASTROSTOMY TUBE. THE PT SUFFERED FROM SKIN CELLULITIS, REQUIRING ANTIBIOTIC TREATMENT OF AUGMENTIN. THE DEVICE WAS REMOVED ON (B)(6) 2011, AND DISCARDED. A FOLEY TUBE WAS PLACED TO AVOID FURTHER SKIN DAMAGE. THE PT WAS UNABLE TO RECEIVE NUTRITION THROUGH THE PEG FOR ONE WEEK AS THE PHYSICIAN WAS NOT AVAILABLE AND THE PT REQUIRED TRANSFER TO THE HOSPITAL FOR THE REPLACEMENT. THE PT OUTCOME AFTER TREATMENT WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT TUBE KNT, TUBES GASTROINTESTINAL AND ACCESSORIES KNT ABBOTT NUTRITION 56548

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Other| R