BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 17723210 · Received September 11, 2023

    Report

    Report Number
    3010757606-2023-00627
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    August 1, 2023
    Report Date
    September 11, 2023
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (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 HAS NOT BEEN RECEIVED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. BEZOAR AND DUODENAL ULCERS ARE KNOWN COMPLICATIONS OF A PEG- J TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE, A PATIENT IN SWITZERLAND UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE PATIENT EXPERIENCED ABDOMINAL PAIN IN THE STOMA AREA. ON (B)(6) 2023, DURING A GASTROSCOPY FOR A TUBING REPLACEMENT, A 5X3 CM SIZED BEZOAR WAS FOUND AT THE END OF THE PEJ IN THE AREA OF THE DESCENDING DUODENAL PARS. THE PULL OF THE PEJ PRODUCED A 1X3 CM LARGE PRESSURE ULCER IN THE PYLORUS/ANGULUS AREA. THE J TUBE WAS NOT REPLACED SO THAT THE ULCER CAN HEAL. DUODOPA PUMP THEREFORE RUNS INTO THE PEG TUBE. THE NEW PEJ DEPOSIT WAS SCHEDULED FOR (B)(6) 2023 AT 11:15 A.M. IN THE MEANTIME, THE PATIENT RECEIVED A HIGH DOSE OF PPI TO HEAL THE ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127427 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32411340

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention PEG TUBE, UNKNOWN MANUFACTURER