BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EZ-BLOCKER ENDOBRONCHIAL BLOCKER

    MDR report key: 3202228 · Received June 28, 2013

    Report

    Report Number
    3003637635-2013-00002
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 27, 2013
    Manufacturer
    CONTRACT MEDICAL INTL. GMBH
    Product Code
    CBI
    PMA / PMN Number
    K121462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE IS UNDER INVESTIGATION AND FOLLOW UP REPORT WILL BE SENT AFTER FINAL INVESTIGATION COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE BALLOON LEAKED PRIOR TO PROCEDURE. NO PATIENT INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295558 RUSCH EZ-BLOCKER ENDOBRONCHIAL BLOCKER CBI CONTRACT MEDICAL INTL. GMBH 557372

    Patients

    Seq Age Sex Outcome Treatment
    1