BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA INTRATHECAL CATHETER KIT

    MDR report key: 8056494 · Received November 9, 2018

    Report

    Report Number
    3010079947-2018-00209
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    October 11, 2018
    Report Date
    October 12, 2018
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020099
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). EVALUATION OF THE DEVICE DETERMINED THAT THE CATHETER WAS DAMAGED. THE CAUSE OF THE DAMAGE IS UNKNOWN; HOWEVER MOST LIKELY DUE TO THE PATIENT FALLING.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE CATHETER WAS REVISED AND A HOLE WAS DISCOVERED IN THE CATHETER. IT WAS ALSO REPORTED THAT IN (B)(6) 2018, THE PATIENT FELL ON ICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894705 PROMETRA INTRATHECAL CATHETER KIT IMPLANTABLE INTRATHECAL CATHETER KIT LKK FLOWONIX MEDICAL, INC. 11823 23554 00810335020099

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention