BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH LARYNGOFLEX RNFRCD TRACH

    MDR report key: 3963207 · Received May 20, 2014

    Report

    Report Number
    9610520-2014-00008
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 22, 2014
    Manufacturer
    WILLY RUSCH GMBH,
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 THE CUFF OF THE DEVICE BECAME UNSTUCK AND DEFLATED DURING MANIPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298564 RUSCH LARYNGOFLEX RNFRCD TRACH TRACHEOSTOMY TUBE FOR LARYNGECTOMY BTR WILLY RUSCH GMBH, 13451

    Patients

    Seq Age Sex Outcome Treatment
    1