BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 18359509 · Received December 19, 2023

    Report

    Report Number
    3010757606-2023-00862
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 21, 2023
    Report Date
    December 19, 2023
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 062910. THE DEVICE INVOLVED IN THE EVENT REMAINED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. PERITONITIS 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 (B)(6) 2023, A PATIENT IN FRANCE UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. THE PATIENT COMPLAINED OF PAIN, AND ON 23 NOV 2023, A SCAN DEMONSTRATED PERITONITIS WITH GASTRIC ORIGIN BECAUSE THE TUBING WAS NOT IN ADHERENCE INSIDE THE INTESTINE. THE SAME EVENING, THE PERITONEUM WAS CLEANED AND THE TUBING WAS PULLED CORRECTLY. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTIC THERAPY, CEFTRIAXONE 1GR (2GR/D) FOR 5 DAYS COMBINED WITH FLAGYL 500MG (1500MG/D) FOR 7 DAYS. ON 27 NOV 2023, DUODOPA TREATMENT WAS RESTARTED. THE PATIENT WAS NOW AFEBRILE AND HAD NO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110205 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R J TUBE, UNKNOWN MANUFACTURER