BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 22167917 · Received June 9, 2025

    Report

    Report Number
    3010757606-2025-00254
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. STOMA SITE INFECTION IS A KNOWN COMPLICATION OF A PEG 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 THE USA UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE. IN (B)(6) 2025, THE PATIENT EXPERIENCED PURULENT DISCHARGE FROM THE STOMA SITE FOR SEVERAL WEEKS AND WAS TREATED WITH ANTIBIOTIC KEFLEX WITHOUT ANY IMPROVEMENT. THE PHYSICIAN DECIDED TO REMOVE THE EXISTING PEG / J TO LET THE STOMA CLOSE AND REPLACED WITH NEW TUBING AT A NEW LOCATION. AT THE TIME OF REPORT, THE PATIENT STILL HAD PURULENT DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633124 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention ABBVIE J-TUBE, LOT # UNKNOWN