BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 21873632 · Received April 21, 2025

    Report

    Report Number
    3010757606-2025-00182
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    March 17, 2025
    Report Date
    April 21, 2025
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (B)(4). THE DEVICE INVOLVED IN THE EVENT REMAINED IN THE PATIENT; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. POST-OP WOUND INFECTION 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) 2025 A PATIENT IN GERMANY UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE. THE PATIENT RECEIVED AN OPEN PEG IN A CT-GUIDED PROCEDURE. THE INTESTINAL TUBE IS TO BE INSERTED LATER FOR THE TRANSITION TO DUODOPA THERAPY. ON (B)(6) 2025 IT WAS REPORTED THAT ON )B)(6) 2025, A SWAB WAS TAKEN FROM THE PATIENT'S STOMA DUE TO A PERSISTENTLY WEEPING STOMA. THE RESULTS OF THE EXAMINATION WERE AVAILABLE ON (B)(6) 2025: LRE (LINEZOLID-RESISTANT ENTEROCOCCUS) BACTERIA AND E. COLI (ESCHERICHIA COLI) BACTERIA WERE DETECTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS PIPERACILLIN/TAZOBACTAM. IN ADDITION, ANTIBIOTIC GENTAMICIN OINTMENT WAS APPLIED LOCALLY FOR 10 DAYS. SYMPTOMS IMPROVED, AND THE PATIENT WAS DISCHARGED. THE PATIENT IS CURRENTLY RECEIVING PRODUODOPA THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741665 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization| R CONCOMITANT PRODUCT NOT REPORTED.