BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 13545923 · Received February 16, 2022

    Report

    Report Number
    3010757606-2022-00094
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    January 23, 2022
    Report Date
    February 16, 2022
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. THE DEVICE INVOLVED IN THE EVENT REMAINED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. ULCER IS A KNOWN COMPLICATION OF A PEG- J TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. THE DEVICE INVOLVED IN THE EVENT REMAINED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. ULCER IS A KNOWN COMPLICATION 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 (B)(6) 2019, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. AFTER AN UNSPECIFIED AMOUNT OF TIME, DURING A ROUTINE PEG/J TUBE REPLACEMENT, AN ULCER WAS OBSERVED IN THE ANTRUM AND A BIOPSY WAS TAKEN. THERE WERE NO BIOPSY RESULTS YET. THE PATIENT WAS TREATED WITH OMEPRAZOLE 20 MG TWICE A DAY.

    Description of Event or Problem · 0

    ON (B)(6) 2019, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. AFTER AN UNSPECIFIED AMOUNT OF TIME, DURING A ROUTINE PEG/J TUBE REPLACEMENT, AN ULCER WAS OBSERVED IN THE ANTRUM AND A BIOPSY WAS TAKEN. THERE WERE NO BIOPSY RESULTS YET. THE PATIENT WAS TREATED WITH OMEPRAZOLE 20 MG TWICE A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389264 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32411340

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Required Intervention PEG TUBE, UNKNOWN MANUFACTURER