BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE PEG

    MDR report key: 7252845 · Received February 8, 2018

    Report

    Report Number
    3010757606-2018-00089
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 2, 2018
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTRE
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(6). CATALOG NUMBER 062941-001 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. STOMA SITE INFECTION IS A KNOWN COMPLICATION OF A PEG- J TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED WIDESPREAD INFECTION ON PEG AREA AND WAS TREATED WITH ANTIBIOTIC DEVASID 1 GR 2X1. THE PATIENT WAS HOSPITALIZED FOR REMOVAL OF PEG-J TO BE PERFORMED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97506 ABBVIE PEG KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE MEDICAL DEVICE CENTRE 32265205

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R