BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSI SPACESEAL

    MDR report key: 281766 · Received June 9, 2000

    Report

    Report Number
    281766
    Event Type
    Malfunction
    Date Received
    June 9, 2000
    Date of Event
    May 31, 2000
    Report Date
    June 8, 2000
    Manufacturer
    GSI INC.
    Product Code
    GDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OUTER SURFACE OF BALLOON SPLIT AND FRAYED WITH PIECES OF BALLOON BROKEN OFF AFTER INFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GSI SPACESEAL BALLOON TIP CATHETER GDI GSI INC. * 912014

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other