BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWP CATHETER

    MDR report key: 117623 · Received August 28, 1997

    Report

    Report Number
    1217435-1997-00278
    Event Type
    Malfunction
    Date Received
    August 28, 1997
    Date of Event
    July 27, 1997
    Report Date
    July 29, 1997
    Manufacturer
    USCI DIV CR BARD INC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEWED.

    Description of Event or Problem · 1

    THE BALLOON OF THIS DEVICE LEAKED DURING PREP. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWP CATHETER ANGIOGRAPHY CATHETER DQO USCI DIV CR BARD INC NA 08CF0852

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN