BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 13573144 · Received February 21, 2022

    Report

    Report Number
    3010757606-2022-00105
    Event Type
    Injury
    Date Received
    February 21, 2022
    Date of Event
    February 6, 2022
    Report Date
    February 21, 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
    003

    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 WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. BEZOAR 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 WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. BEZOAR 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 AN UNKNOWN DATE, 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) 2022, THE PATIENT WAS DIAGNOSED WITH A BEZOAR. ON AN UNREPORTED DATE, THE J TUBE WAS CUT AND PUSHED INTO THE STOMACH, DUODOPA WAS ADMINISTERED THROUGH THE PEG TUBE UNTIL THE J TUBE CAME OUT IN THE STOOL. ON (B)(6) 2022, IT WAS REPORTED THAT THE J TUBE CAME OUT IN THE STOOL, AND A NEW J TUBE WAS INSERTED.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE, 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) 2022, THE PATIENT WAS DIAGNOSED WITH A BEZOAR. ON AN UNREPORTED DATE, THE J TUBE WAS CUT AND PUSHED INTO THE STOMACH, DUODOPA WAS ADMINISTERED THROUGH THE PEG TUBE UNTIL THE J TUBE CAME OUT IN THE STOOL. ON (B)(6) 2022, IT WAS REPORTED THAT THE J TUBE CAME OUT IN THE STOOL, AND A NEW J TUBE WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673477 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32044209

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention PEG TUBE, UNKNOWN MANUFACTURER