BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE SINUS CATHETER

    MDR report key: 1250864 · Received November 26, 2008

    Report

    Report Number
    1713910-2008-00003
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 14, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    BALLOON RUPTURED DURING USE. NO IMPACT ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE SINUS CATHETER SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 584038

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK