BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 15946272 · Received December 8, 2022

    Report

    Report Number
    3010757606-2022-00803
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    November 24, 2022
    Report Date
    December 8, 2022
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 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. STOMA SITE 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 AN UNKNOWN DATE, A PATIENT IN TURKEY UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. OBN (B)(6) 2022, THE PATIENT EXPERIENCED REDNESS AND DISCHARGE IN THE STOMA AREA AND WAS DIAGNOSED WITH AN INFECTION AT THE WOUND SITE. ANTIBIOTIC TREATMENT SULCID 1 GR FLK I.V WAS STARTED BECAUSE STAPHYLOCOCCUS AUREUS GREW AS A RESULT OF THE WOUND CULTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2841972 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32235109

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention J TUBE, UNKNOWN MANUFACTURER