BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 6FR 100% SILICONE FOLEY 1

    MDR report key: 3955747 · Received June 12, 2014

    Report

    Report Number
    8040412-2014-00126
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 16, 2014
    Product Code
    KOD
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: IT WAS REPORTED THAT THE CATHETER BROKE AT THE FUNNEL WHEN TESTED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347895 RUSCH 6FR 100% SILICONE FOLEY 1 FOLEY CATHETER KOD 13EE20

    Patients

    Seq Age Sex Outcome Treatment
    1