BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 17286042 · Received July 10, 2023

    Report

    Report Number
    3010757606-2023-00461
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    April 20, 2023
    Report Date
    July 7, 2023
    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 · 0

    REFERENCE RECORD (B)(4). CATALOG NUMBER IN D4 IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. THE DEVICE INVOLVED IN THE EVENT WAS REMOVED FROM THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. H6 CODE OF 4581 WAS CHOSEN TO CAPTURE THE EVENT OF INTESTINAL OBSTRUCTION. INTESTINAL OBSTRUCTION IS A KNOWN COMPLICATION OF A PEG- J TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MED-WATCH WILL BE FILED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2023, THE PATIENT WAS HOSPITALIZED FOR AN INTESTINAL OBSTRUCTION. ON (B)(6) 2023, THE PATIENT UNDERWENT A CT SCAN THAT REVEALED THAT THE PEJ WAS FOUND TO BE TIGHTLY ENCAPSULATED WITH FOOD DEBRIS IN THE SMALL INTESTINE WHICH CAUSED THE INTESTINAL OBSTRUCTION. IT WAS REPORTED THAT THE PEJ WAS REMOVED AND A NEW PEJ WAS PLACED AT THAT TIME. THE PATIENT WAS TREATED WITH AN UNKNOWN INTRAVENOUS ANTIBIOTIC FROM (B)(6) 2023 TO (B)(6) 2023. ON (B)(6) 2023, THE PATIENT WAS DISCHARGED. ON (B)(6) 2023, THE PATIENT HAD A CHECK UP AND REPORTED FEELING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168267 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32451350

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R UNKNOWN PEG-TUBE, LOT # UNKNOWN