BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH RR MAGIL/CUFFED ET TUBE, 3.0MM

    MDR report key: 2864480 · Received December 6, 2012

    Report

    Report Number
    9610520-2012-00018
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 21, 2012
    Manufacturer
    WILLY RUSCH GMBH
    Product Code
    BYW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT ET TUBE HAS A DEFECT AND IT SEEMS TO BE LEAKY. PATIENT IS FINE. NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH RR MAGIL/CUFFED ET TUBE, 3.0MM RED RUBBER ENDOTRACHEAL TUBE BYW WILLY RUSCH GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1