BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 12677337 · Received October 21, 2021

    Report

    Report Number
    3010757606-2021-00720
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    September 1, 2021
    Report Date
    October 21, 2021
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4). CATALOG NUMBER IN IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION, IT WAS DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION WAS NOT PERFORMED. BEZOAR IS A KNOWN COMPLICATION OF USE OF DEVICE. (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, PATIENT IN (B)(6) UNDERWENT PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY WITH JEJUNAL (PEG-J) TUBE. THE REPORT INDICATED THAT THERE WAS A BEZOAR AT THE END OF JEJUNAL TUBE. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573231 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32341119

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention