BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK ENDO FASCIAL CLOUSRE SYSTEM

    MDR report key: 4088315 · Received August 1, 2014

    Report

    Report Number
    1044475-2014-00195
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 7, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER BUT THE INVESTIGATION HAS NOT BEEN COMPLETE AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: IT WAS REPORTED THAT DURING INSERTION THE NEEDLE IN THE EFX THERE WAS RESISTANCE AND THE EFX BROKE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449529 WECK ENDO FASCIAL CLOUSRE SYSTEM NONE GCJ TELEFLEX EF038415

    Patients

    Seq Age Sex Outcome Treatment
    1