BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 10433836 · Received August 20, 2020

    Report

    Report Number
    3010757606-2020-00543
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    July 26, 2020
    Report Date
    July 29, 2020
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE NUMBER (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. THE DEVICE INVOLVED IN THE EVENT REMAINED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. POST PROCEDURAL COMPLICATION IS A KNOWN COMPLICATION OF A PEG- J TUBE PLACEMENT. (B)(4). IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE REPLACEMENT OF PERCUTANEOUS ENDOSCOPIC JEJUNAL TUBE. ON (B)(6) 2020, THE PATIENT EXPERIENCED A STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897981 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32341159

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention