BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE PEG

    MDR report key: 5611152 · Received April 27, 2016

    Report

    Report Number
    3010757606-2016-00085
    Event Type
    Injury
    Date Received
    April 27, 2016
    Date of Event
    April 12, 2016
    Report Date
    April 12, 2016
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE MANUFACTURER HAS BEEN IDENTIFIED AS ABBVIE INC.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 MANUFACTURER AND LOT NUMBER OF THE PEG TUBE INVOLVED IN THIS EVENT WAS NOT PROVIDED BY THE COMPLAINANT. THEREFORE, IT IS UNKNOWN IF THE TUBING INVOLVED WAS THE ABBVIE PEG TUBE. CONSERVATIVELY, ABBVIE HAS CHOSEN TO REPORT THIS EVENT DUE TO THE POTENTIAL THAT THE PEG TUBE INVOLVED COULD HAVE BEEN THE ABBVIE PEG TUBE. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, A BATCH RECORD REVIEW COULD NOT BE CONDUCTED. A RETURN SAMPLE EVALUATION WAS NOT PERFORMED BECAUSE TUBING WAS NOT RETURNED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) EXPERIENCED LEAKING FROM THE DISTAL CONNECTORS OF A PERCUTANEOUS ENDOSCOPIC GASTRO JEJUNOSTOMY (PEGJ) TUBE. THE PATIENT HAD A SMALL GRANULOMA AND THE PHYSICIAN DECIDED TO EXCISE IT. ON (B)(6) 2016, THE PEGJ SYSTEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266619 ABBVIE PEG KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention