BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSFLEX LC OTW

    MDR report key: 250524 · Received November 16, 1999

    Report

    Report Number
    1016427-1999-00234
    Event Type
    Malfunction
    Date Received
    November 16, 1999
    Report Date
    November 15, 1999
    Manufacturer
    CORDIS CORP.(MIAMI)
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PINHOLE LEAKAGE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSFLEX LC OTW Implant CORONARY SDS/STENTS MAF CORDIS CORP.(MIAMI) NA A0799033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN