BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 281779 · Received June 9, 2000

    Report

    Report Number
    281779
    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 BREAKING OFF AFTER INSUFFLATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR