BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 20276275 · Received September 22, 2024

    Report

    Report Number
    3010757606-2024-10095
    Event Type
    Injury
    Date Received
    September 22, 2024
    Date of Event
    August 1, 2024
    Report Date
    September 22, 2024
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE MANUFACTURER AND LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. THEREFORE, IT IS UNKNOWN IF THE DEVICE INVOLVED WAS ABBVIE BRANDED TUBING. CONSERVATIVELY, ABBVIE HAS CHOSEN TO REPORT THIS COMPLAINT DUE TO THE POTENTIAL THAT THE DEVICE INVOLVED COULD HAVE BEEN ABBVIE BRANDED TUBING. 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.

    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 AUG 2024 THE SPOUSE REPORTED THAT THE PATIENT HAD AN INFECTION AROUND THE STOMA SITE WITH DRAINAGE. IT WAS REPORTED THAT THE PATIENT RECEIVED UNSPECIFIED ORAL ANTIBIOTICS FOR THE PEG/J. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386587 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention J TUBE, UNKNOWN MANUFACTURER