BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPI-MED

    MDR report key: 468758 · Received June 24, 2003

    Report

    Report Number
    MW1028829
    Event Type
    Malfunction
    Date Received
    June 24, 2003
    Date of Event
    June 18, 2003
    Report Date
    June 24, 2003
    Manufacturer
    EPI-MED
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE ATTEMPTED TO REMOVE NEUROPLASTY CATHETER AND WAS UNABLE TO. FELT A SHARP RELEASE AND CATHETER WIRE SEEN UNRAVELING. TAPED IN PLACE AND DOCTOR CALLED TO REMOVE CATHETER. PT TO FLUOROSCOPY FOR EXAM AND ALL PHOTOS WERE OKAY. PLASTIC END APPEARS JAGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPI-MED TUN-L-KATH NEUROPLASTY CATHETER BSO EPI-MED 155-1520 1120738

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other