BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 23214406 · Received October 3, 2025

    Report

    Report Number
    3015537318-2025-00084
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    September 6, 2025
    Report Date
    October 2, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INITIAL INFORMATION THAT INTERA ONCOLOGY RECEIVED FROM THE PHYSICIAN DOES NOT ALLEGE A DEVICE MALFUNCTION TAKING PLACE. THE WOUND DEHISCENCE IS AN ADVERSE EVENT THAT WAS LIKELY CAUSED BY THE PATIENT'S CONDITION. INTERA ONCOLOGY HAS SENT COMMUNICATION TO THE CLINIC TO INQUIRE ABOUT THE CAUSE OF THE DEHISCENCE AND TO DATE A RESPONSE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT FROM A PHYSICIAN ABOUT A PATIENT DEVELOPING A DEHISCED WOUND. ON (B)(6) 2025, THE PATIENT WAS TAKEN INTO THE OR AND THE PUMP WAS EXPLANTED. ON THE SAME DAY, THE PHYSICIAN IMPLANTED A NEW PUMP (SERIAL NUMBER (B)(6)). WHEN OUR REPRESENTATIVE CALLED FOR MORE INFORMATION, THE OR NURSE MENTIONED THAT THE PHYSICIAN TOOK CARE OF EVERYTHING AND DID NOT NEED ASSISTANCE WITH ANYTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236227 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30402081

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention