BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 20286991 · Received September 23, 2024

    Report

    Report Number
    3015537318-2024-00081
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 23, 2024
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTERA ONCOLOGY COMMUNICATED WITH THE PATIENT'S PHYSICIAN. THE PATIENT'S PHYSICIAN STATED THAT THE CAUSE OF THE BRUISE WAS LIKELY POST OP FROM PLACEMENT. THE PATIENT DID NOT SEEK MEDICAL ATTENTION. IN ADDITION, IT WAS CONFIRMED THAT THE FLUID IN THE PATIENT'S PUMP POCKET WAS RELATED TO SEROMA.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT THAT A PATIENT HAD BRUISES AROUND THE WHOLE PERIMETER OF THE PUMP AFTER REFILL. THE BRUISING WAS FIRST NOTICED AFTER THE APPOINTMENT WHICH TOOK PLACE ON (B)(6) 2024. IN ADDITION, THE PATIENT STATED THE AREA WAS SORE. THE PATIENT THEN WENT ON TO SAY THAT SHE HAD FLUID IN THE PUMP POCKET WHICH WAS FIRST NOTICED ONE WEEK AFTER HER PUMP PLACEMENT SURGERY WHICH TOOK PLACE ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015694 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 28155410S 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other