BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 20027642 · Received August 22, 2024

    Report

    Report Number
    3015537318-2024-00069
    Event Type
    Injury
    Date Received
    August 22, 2024
    Report Date
    August 16, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEROMA IS A KNOWN ADVERSE EVENT AS LISTED ON THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP IFU. BLANK FIELDS IN THE MDR REPRESENT UNKNOWN INFORMATION AT THE TIME OF THIS REPORT. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO INTERA ONCOLOGY BY A HEALTHCARE PROVIDER THAT A PATIENT WITH AN INTERA 300 HEPATIC ARTERY INFUSION PUMP HAD RECURRENT SEROMA. THE HCP INDICATED THE TREATING MEDICAL ONCOLOGIST HAS DRAINED A PUMP POCKET SEROMA "SEVERAL TIMES" AND WAS WONDERING ABOUT SCLEROTHERAPY TREATMENT APPROACHES TO TREAT THE RECURRENT SEROMA. PATIENT INFORMATION, DATE OF EVENT, SERIAL NUMBER, AND OTHER IDENTIFYING INFORMATION WAS NOT PROVIDED BY THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013074 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention