BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWP CATHETER

    MDR report key: 95443 · Received May 29, 1997

    Report

    Report Number
    1217435-1997-00175
    Event Type
    Malfunction
    Date Received
    May 29, 1997
    Date of Event
    May 5, 1997
    Report Date
    May 6, 1997
    Manufacturer
    USCI DIV CR BARD INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO CO THAT THE BALLOON OF THIS DEVICE LEAKED DURING PREP. THERE WAS NO PATIENT INVOLVEMENT, THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWP CATHETER ANGIOGRAPHY CATHETER DQO USCI DIV CR BARD INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN