BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 14473638 · Received May 23, 2022

    Report

    Report Number
    3010757606-2022-00344
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    May 9, 2022
    Report Date
    July 5, 2022
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (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 IMPLANTED 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 TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    REFERENCE RECORD 2043349. ADDITIONAL INFORMATION ADDED TO B5, H6. 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 AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED DUE TO A FEVER, LOW BLOOD PRESSURE, AND A STOMA INFECTION. THE STOMA WAS VERY INFLAMED AND WAS TREATED WITH UNKNOWN INTRAVENOUS (IV) ANTIBIOTICS. THE STOMA INFLAMMATION SUBSEQUENTLY IMPROVED.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT REPORTED THAT DURING THE HOSPITALIZATION, SHE WAS DIAGNOSED WITH ASPIRATION PNEUMONIA AND SEPSIS. IT WAS UNKNOWN IF THE SEPSIS WAS RELATED TO THE STOMA SITE INFECTION. THE PATIENT REPORTED THAT THE STOMA IS STILL WEEPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764822 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Hospitalization| R J-TUBE- UNKNOWN MANUFACTURER AND LOT #