BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTI [QUE] BALLOON

    MDR report key: 504173 · Received January 2, 2004

    Report

    Report Number
    504173
    Event Type
    Other
    Date Received
    January 2, 2004
    Date of Event
    September 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DQO
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN OPTI [QUE] BALLOON WAS RUPTURED. THE STERILE SLEEVE COULD HAVE RUPTURED IT OR IT MAY HAVE BEEN OVERINFLATED. THE DEVICE MAY NOT HAVE BEEN TESTED PRIOR TO USE AND MAY HAVE DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI [QUE] BALLOON CENTRAL LINE DQO ABBOTT LABORATORIES 52510 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other STERILE SLEEVE.