BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 10514827 · Received September 10, 2020

    Report

    Report Number
    3010757606-2020-00581
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    August 1, 2020
    Report Date
    September 10, 2020
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. (B)(4). 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. 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. ON (B)(6) 2020, A DEVICE REPLACEMENT WAS PERFORMED AND A PHYTOBEZOAR WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980344 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention PEG TUBE - MANUFACTURER UNK