BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 12461140 · Received September 13, 2021

    Report

    Report Number
    3010757606-2021-00625
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    August 1, 2021
    Report Date
    September 13, 2021
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    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. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. BEZOAR 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, PATIENT IN (B)(6) UNDERWENT PROCEDURE FOR THE REPLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY WITH JEJUNAL (PEG-J) TUBE. THE REPORT INDICATED THAT THE JEJUNAL TUBE HAD A LARGE BEZOAR. THE DEVICE HAS BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359984 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ABBVIE PEG TUBE- LOT NUMBER UNK