BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 24847841 · Received April 11, 2026

    Report

    Report Number
    3015537318-2026-00029
    Event Type
    Injury
    Date Received
    April 11, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 10, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERA ONCOLOGY HAS REACHED OUT TO THE PHYSICIAN MULTIPLE TIMES TO SEEK ADDITIONAL INFORMATION. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED. THEREFORE, IF WE RECEIVE ADDITIONAL INFORMATION FROM THE PHYSICIAN, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A COMPLAINT REPORT ABOUT A PATIENT HAVING PUMP POCKET SEROMA. WHILE BEING A RELATIVELY MINOR COMPLICATION. ACCORDING TO THE PHYSICIAN, FOR 1 PATIENT, SOMETIMES IT CAN TAKE 2 OR 3 TIMES TO DRAIN THE SEROMA WHEN THE PATIENT COMES FOR THEIR REFILL. THE PHYSICIAN ACKNOWLEDGES THAT THIS IS A KNOWN COMPLICATION WHEN LOOKING AT THE MEMORIAL SLOAN KETTERING DATA AND DATA FROM THE ENTIRE HAI CONSORTIUM, PUMP POCKET COMPLICATIONS ARE THE MOST COMMON COMPLICATIONS. SEROMA WAS THE MOST COMMON THEY SAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119486 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other