BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH

    MDR report key: 347954 · Received August 16, 2001

    Report

    Report Number
    2429473-2001-00151
    Event Type
    Malfunction
    Date Received
    August 16, 2001
    Report Date
    August 15, 2001
    Manufacturer
    RUSCH, INC.
    Product Code
    KCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THERE WAS ROUGH SUBSTANCE AT THE TOP OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37490 RUSCH HURST ESOPHAGEAL BOUGIE 58F KCD RUSCH, INC. NA 103268

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN